TYPE OF ALERT: Automatic Detention
IA#89-08, -----8/11/92 REVISED ATTACHMENT 01/29/01
TYPE OF ALERT: Automatic Detention
PRODUCT : Class III medical devices for which there are not approved PMA's or Investigational Device Exemptions (IDE), and all other devices that have not been determined substantially equivalent
or for which a 510(k) has not been filed.
PRODUCT CODE: Multiple
HARMONIZED
CODE : N/A
PROBLEM : Devices are being distributed without a 510(k) or approved PMA and are not the subject of an IDE.
COUNTRY : See Attachment
MANUFACTURER
or SHIPPER : See Attachment
MANUFACTURER
SHIPPER I.D.#: N/A
IMPORTER'S
I.D.# : N/A
CHARGE : For Class III device:
"The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the device appears to be a Class III device and does not appear to have in effect an approved application for premarket
approval pursuant to Section 515 of the Act, or an exemption pursuant to Section 520(g)(1)
[Adulteration, Section 501(f)(1)(B)]."
For other devices:
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears
to be a post 1976 device for which a Section 510(k) application has not been determined substantially
equivalent or a 510(k) has not been filed [Misbranding, Section 502(o)]
RECOMMENDING OFFICE : CDRH, Office of Compliance and Surveillance
Division of Compliance Operations
Regulatory Guidance Branch HFZ-323
REASON FOR
ALERT : Devices listed in the Attachment lack either a filed 510(k) or approved PMA (Pre Market Approval) for commercial distribution.
INSTRUCTIONS: Automatically detain all devices, as designated, from the manufacturers listed in the Attachment.
FOI : Purging between ^ ^ is required
KEYWORDS : 510(k), PMA, IDE, Medical devices, devices, Class III devices, Pre Market Approval
Attachment to Import Alert #89-08 Revised 01/29/01
The following devices and firms are under automatic detention:
Manufacturer Device(s) / Date Added Class
ALL COUNTRIES
All foreign manufacturers of Hyperbaric Chambers
Hyperbaric Chambers Product Code 73CBF -10/29/99
All Countries
Little Sentry Junior Infant Breathing Monitor/73F 10/30/00
This product was initially recommended for DWPE based on the actions of one firm that was promoting the product in the United States (U.S.). CDRH has become aware that other firms may be shipping this device to the U.S. with the following claims:
"The Little Sentry Junior gives parents and healthcare professionals the opportunity to resuscitate babies whose breathing has stopped."
"The Little Sentry Junior Monitors the breathing movements of a baby."
"Should the breathing movements stop for a period exceeding 20 seconds, a loud pulsing alarm accompanied by a red warning light on the monitor is activated."
These types of claims cause the Little Sentry Junior Infant
Breathing Monitor to be classified as a device.
Firm(s) Product(s)/Code(s)
All Countries 
87KXC, 87KMD, 87HSN and/or 87MBK - 11/22/00
This product was initially recommended for DWPE based on the actions of one firm that was promoting the product(s) in the United States (U.S.). CDRH has become aware that other firms may be shipping these devices to the U.S. The product is classified as a device, and is of concern when totally or partially constructed of the following:
C. Polytetrafluoroethylene(a.k.a. P.T.F.E., Teflon or Proplast)
C. Without an approved IDE or PMA, or cleared PMN (510(k).
C. The product lacks safety and effectiveness data for PTFE ankle devices specifically, and historical safety issues with PTFE joint replacement devices.
AUSTRALIA
Australian Light Therapy Seasonal Affective Disorder Device 108 Forrest St. (SAD Lights) (2/4/92) III Cottesloe, W.A. 6011 Australia
Manufactured in China for: "Oradam" latex facial ^ ^ 1/20/95
BAHAMAS
IHT Limited HIV Oral Test
P.O. Box N4361 (aka HIV 1,2 & Subtype O Saliva Test) III
Nassau, Bahamas 82---/10/26/99 FEI# 3002835158
Newco Associates HIV Oral Test P.O. Box CB12611 (aka HIV 1,2 & Subtype O Saliva Test) III Nassau, Bahamas 82---/10/26/99 FEI# 3001680610
BRITISH VIRGIN ISLANDS (VG)
World Health Diagnostics, Inc. HIV 2 Blood test kit P.O. Box 362, Roadtown (a.k.a. HIVTESTINGKIT) Tortola, VG 82- - - ,57YY99 FEI # 3003016883 5/25/00
Note: HIV diagnostic test kits are Class III devices within the meaning of Section 513(f)(1) of the Act and are regulated by CBER under the current intercenter agreement between CDRH and CBER. The unapproved diagnostic test kits claim to detect HIV antibodies in blood or saliva and provide results in the home in 15 minutes or less.
The test kits are imported into the U.S. through the mail and may be entered as Asamples@ or for A personal use@.
The contents may be labeled Afor investigational use@, for Aresearch use@, or Afor export only.@ The test kits could present a serious hazard to the public health, including possible HIV transmission to partners and delayed access to medical care due to mis-diagnosed false negative tests. If entries are encountered, contact CBER Import/Export Team at 301-827-6201.
CANADA (CA)
Angel & Company Angelcare Sound - 12/15/98 P.O. Box 879 & Breathing Frequency Knowlton, Quebec, Canada Monitor FEI#: 3002528073 Product Code: 73BZQ
Aqua Sole Company Ltd. Eye Mask (or Eye Masque) 27 Passmore Avenue, Unit #1 Scarborough, Ontario M1V 4T4 Canada MID #XOAQUSOL27SCA
A & T Company HIV 1/2 Saliva Test Kit 43 Vanity Crest (aka Easy Home Test or easyhivtest) Richmond Hill, Ontario Product Code: 82[][][], 57YY99 L4B 4E5 Canada 9/14/00 FEI# 3003109775
Note: HIV diagnostic test kits are Class III devices within the meaning of Section 513(f)(1) of the Act and a re regulated by CBER. The unapproved diagnostic test kits claim to detect HIV antibodies in blood or saliva and provide results in the homein 15 minutes or less.
The test kits are imported into the U.S. through the mail and may be entered as "samples" or for "personal use." The contents may be labeled "for investigational use," for "research use," or "for export only." The test kits could present a serious hazard to the public health, including possible HIV transmission to partners and delayed access to medical care due to misdiagnosed false negative tests. If entries are encountered, contact CBER Import/Export Team at (301) 827-6201.
BioChem ImmunoSystems, Inc. BioChem SELECT-HIV Kit 10900 Hamon St. Product Code: 57YY99 Montreal, Quebe 7/27/98 c Canada FEI #1000229412
Biotronix 2000, Inc. NeedleSafe, all models 2185 Michelin including NX3000, NX2000, Laval, Quebec NX1000, NX5000 SDS; 80KDB Canada H7L 4S2 & FEI# 3002129220 Sharpes Container sold with Model NX5000 SDS and alone; 80MMK - 8/19/98
THE FOLLOWING FIRM (AND PRODUCTS) WAS NOTED ON THEIR INTERNET WEB SITE OFFERING FOR SALE VARIOUS UNCLEARED MEDICAL DEVICES TO CITIZENS OF THE UNITED STATES. THE DEVICES APPEAR TO PREVENT PREGNANCY AND DISEASE TRANSMISSION, WHICH REQUIRE MARKETING CLEARANCE AND MAY NOT BE LEGALLY MARKETED IN THE UNITED STATES (US) WITHOUT SUCH CLEARANCE. THE DEVICES ARE CONSIDERED ADULTERATED UNDER SECTION 501(f)(1)(B) AND MISBRANDED UNDER SECTION 502(o) OF THE ACT AND MAY BE IN VIOLATION OF TITLE 21 OF THE UNITED STATES CODE, SECTION 331(a) AND 331(d).
BIRTHCONTROL.COM LEA SHIELD (BARRIER) 85LLQ 1269 56TH. STREET #18037 ANTYCONDOM 85LTZ DELTA, BC. CANADA C4L2M4 UNISEX CONDOM 85MEE FEI# 3002983254 DENTAL DAM Correction 5/2/00 OVU-TRAC (OTHER ADDRESSES) LADYCOMP AND BABYCOMP COMPUTERS 188-3854 GORDON DR. OVES CONTRACEPTIVE CAP KELOWMA, BC. CANADA FEI # 3001066002
BOX 25006 MPPO KELOWMA, BC. CANADA FEI # 3001159362
Comptronics Devices Limited Oasis Cranial Electrotherapy Stimulator 9008-51 Avenue (CES) Edmonton, Alberta 84 JXK Canada 6/29/00 FEI # 3003046588
Fidelity Electronics of Canada (Shipper) 5/6/94 5696 Ambler Drive Mississauga, Ontario, Canada L4W 2K9 MID# XOFIDELE5696MIS
Health Care Products, Inc. Wipeout Long Life Activated N/A 165 Matheson Blvd. E., Suite 8 Dialdehyde Mississauga, Ontario, (4/27/93) Canada L4Z3K2 ID# XOHEACAR165MIS
Health Light, Inc. Seasonal Affective III P.O. Box 3899 Station C Disorder Device Hamilton, Ontario L8H 7P2 (SAD Lights) Canada (2/4/92)
International Biotech Corporation HIV 1/2 Blood Test Kit #616, 10216-124 Street (aka V-Scan HIV-1 & HIV-2) Edmonton, Alberta, T5N 4A3, Canada 82[][][], 57Y[][]99 FEI# 3002848449 11/9/99
J.K. Orthomedic, Ltee. LARS (Ligament Advanced a.k.a. Kirschner Canada Reinforced System) 1755 St. Regis 210 PRODUCT CODE: 87LML Dollard-des-Ormeaux 10/13/95 Quebec, Canada H9B2M9
Medevice Inc. Bio-Mate Spinal Catheter 5080 Timberlea Blvd. 2/25/93 Unit 11, Mississauga Ontario, L4W 4M2 Canada XOMEDINC508OMIS
Medionics International, Inc. QC Transfer Sets Plant: 114 Anderson Avenue 12/15/92 Markham, Ontario L6E 1A5 Canada MID# XOMEDINT114MAR
Office: 1271 Denison Street Suite 4950 Markham, Ontario L3R 4B5 Canada MID# XOMEDINT4950MAR
Northern Light Thechnologies Seasonal Affective Disorder III 3070 Brabant-Marineau St. Device (SAD Lights) St. Laurent, Quebec I4S 1K7 (2/4/92) Canada
Nordion International, Inc. Validose Dosimetry System II 447 March Road 8/17/93 P.O. Box 13500 Kanata, Ontario Canada K2K 1X8 MID# XONORINT1350KAN
Preferred Medical Products Spinal anesthesia III 3280 Schmon Parkway trays containing Thorold, Ontario L2V 4Y6 tetracaine hydrochloride Canada for use in the pediatric population
ID# XOPREMED3280THO Continuous Spinal Anethesia III Trays (non-pediatric) (3/5/93)
Epi-Spinal Tray-Reorder #2002 III Epi-Spinal Mini Kit-Reorder #2005 III (7/30/93)
Seville Marketing Discreet HIV Test III 3017 Mountain Way 82---/10/26/99 P.O. Box 16047 North Vancouver, BC, V7J 2R0 Canada FEI# 3002764311
Sota Instruments Inc. The Zapper, Mo. #ZHC3/84--- P.O. Box 1269 The Silver Marker, Mo. #CSG2/ Revelstoke 84--- BC, Canada 10/19/00 VOE 2S0 FEI #3002598721
Sudor, Inc. Ground Zero, P.O. Box 383 Ground System and Collingwood Ontario methods for organisms Canada L9Y 3Z7 (Ground Zero Grounding Device) FEI # 3002828315 Product Code 84- - - 10/20/99
* Tri Hawk International Histoacryl Tissue III 1570 Rue Bane Adhesive Montreal, Quebec, Canada, H4L 4M6 5/11/93 *(Shipper for B. Braun Melsungen AC.)
Ultrasoft Laboratories Contact Lenses (all types) II 8855 Northbrook Court 2/9/93 Burnaby, British Columbia V5J 5G1 Canada ID# XCULTLAB8855BUR ID# XCULTSOF4025BUR
Yocan Medical Systems Inc Histoacryl Tissue Adhesive (MAY ALSO BE III 4 Spirea Ct. IDENTIFIED AS BIOLOGICAL GLUE) Thornill, Ontario, Canada 84KGG L3T 2W1 79MFI FEI #1000189357 (NOTE: PRODUCT HAS ALSO BEEN CODED AS A DRUG UNDER 66V--99) 12/17/98
CHINA, PEOPLES REPUBLIC Guanzhou HuaNan Medical Positive/Negative Pressure Apparatus Co., Ltd. (MFR.) Integrated Computer Control 212 Xingang W. Rd. Augmented Sequential External Guangzhou, 510300, China Counter-Pulsation Devices FEI# 3001403711 Prod. Code 89[][][] 2/24/98
Shipper for Guanzhou HuaNan:
Shandong Medicines & Health Products Import/Export Corp. 16 Baoding Road Qindao, China FEI# 3000246908
China National Agricultural Machinery Universal Massage Shenzhen, China Apparatus MID #CNCHINATSHE 11/30/94
Chongqing Bashan Instrument Factory TDP Special Electromagnetic 83 Shi Xin Road Therapeutic Apparatus Chongqing, PRC 630039 80ILY FEI# 3000983373 8/19/97
Doo Jung H.K. Limited Pap Smear Brushes (may be II Kwan Lan Town shipped as cosmetic brushes Tai Wo Village or may be brush head only. Shenzhen, China 6/8/93 ID#: CNDOOJUNSHEN
Hsin Ten Health and Wealth Industry (HEFEI) Co. Ltd. 4/24/00 Hot House YS-50 FIR 669 Changjiang West Road Health Builder Heifei, China 89ILY FEI # 3002989940
CZECH REPUBLIC
Gel-Med International ***DILAPAN Hygroscopic III spol s.r.o. Cervical Dilators V Cibulkach 51, DILAPAN-S Hygroscopic 150 00 PRAHA 5 Cervical Dilators Czech Republic 6/26/96 FEI# 1000573518 85MCR
***(DILAPAN Hygroscopic Cervical Dilators may be identified as being manufactured and distributed under the label >>"Gynotech, Inc., Middlesex, New Jersey<<") and DILAPAN-S Hygroscopic Cervical Dilators may be identified as being distributed under the label "FEMA INTERNATIONAL") and shipped by:***
***Shipper: Kamedico Health Care Products, Inc. 1759 West 3rd Avenue Vancouver, B.C., Canada V6J 1K7 FEI# 1000371924 MID# XCKAMHEA1759VAN
***Be aware that the U.S. manufacturer of the DILAPAN cervical dilators is ^ ^ who is presently under injunction since these devices were manufactured in the absence of a valid supplemental PMA and contrary to applicable good manufacturing practices (GMPs).***
DENMARK
Ambu International A/S Ambu Cariopump ACD Resuscitator SDR. Ringvej 49 4/29/94 2600 Glostrup Denmark MID #DKAMBINT215GLO
FINLAND
Labsystems OY Tetanus IgG EIA Kit II Pulttitie 8 P.O. Box 8 00880 Helsinki, Finland ID#: FILABOY8HEL (6/4/93)
FRANCE
Burnet Laboratoire Sterile Surgical Gloves III Pharmaceutique Av. Georges Denos, B.P. 61 72403 La Ferte Bernard, France
ELA Medical Chorus RM cardia pacemaker model 7034 III 98-100 Rue Maurice Arnoux (9/9/92) 92120 Montrouge, France Chorus II cardia pacemaker Model 6234 III (9/9/92)
Laboratoires Eurosilicone All Devices III 21, rue Francis Combe 12/28/94 95000 Cergy Pontoise France MID# FRLABEUR21PON
Laboratory Nycomed Polyvinyl Alcohol Foam III Ingenor SA, 25 Quai Particles PVA Foam) and de la Gare-C.E. Balloon Catheters No.19 F-75644 Paris Cedex 13 France
LARS LARS (Ligament Advanced 5 Rue de La Fontaine Reinforced System) Arc Surtille PRODUCT CODE: 87LML France 21560 10/13/95
Medical Z, S.A. All Scar Management BP 39, 55, Rue De L'Eglise Gel Products (Medigel Z) 61110 Remalard 79MDA France 11/27/96 FEI #1000656612 MID #FRMEDSA55REM
Opsia Laboratories All 100% Perflourodecalin III 10, Avenue De L'Europe DK Lines Ramonville-Saint-Agne France
Orthomed Ligastic artificial 256 Rue Vignes Dardelain ligament(s) 21160 Marsannay LaCote PRODUCT CODE: 87LML Dijon, France 10/13/95
SAPP #4 Rue Cozette Audiokinetron Device 8000 Amiens Product code 76MGE France (3/29/94) MID #FRSAP4AMI
Tomatis Electronics Electronic Ear, or any device 56 Rue Des Batignolles labeled or marked for auditory 75017 Paris training, auditory integration, France or behavioral improvement. FEI #3000190157 2/5/97 MID #FRTOMELE76PAR
AND PRODUCT CODE 84GWJ Tomatis International 2/5/97 6, Place de la Republique - Dominicaine 75017 Paris France FEI #3000190169 MID #FRTOMINT6PAR
GERMANY
Aesculap Aktiengesellscraft Heifetz Skull Perforator Drill (only) III Postfach 40 (11/5/92) D-7200 Tuttlingen, Germany
B. Braun Melsungen AC. Histoacryl Tissue III Carl Braun Strasse 1 Adhesive Melsungen, West Germany ID# DEBRAMEL1MEL
*Beltex Histoacryl Tissue III C.P. 222 Adhesive St. Sulpice, Quebec, J6K 3JO (5/11/93) ID# XQBEL222STS *(Shipper for B. Braun Melsungen AC.)
Kendall Germany CURITY Continuous III CDK Holding GmBH Spinal Anesthesia Raffineriestr, 8 Tray
COSPAN Continuous III Spinal Anesthesia Tray
COSPAN Pediatric III Spinal Anesthesia Tray
CURITY Pediatric III Continuous Spinal Anesthesia Tray
Leibinger GMBH Total Joint or Condylar protheses for III Schutzenstrabe 5-7 the Temporomandibular joint (TMJ) D7200 Tuttlingen (4/16/93) Germany, Federal Rep. of ID# DELEIGMB57TUT
U.S. Distributor:^
Novafon Elektromedizinche Therapeutic Massagers: Gerate GmbH (aka Novafon GmbH) Novafon SK1 Sound Stuttgart, W. Germany Wave Appliance III
ID# DENOVELE7000STU Nostrafon SK2 Sound III or DENOVGMB7000STU Wave Appliance
Medi-pol, (magnetic field III therapy attachment used as an accessory device with Nostrafon unit)
Rheinmagnet, Inc. Magnetic Devices Germany No classification name, FEI #1000490604 number, or regulation citation MID #DERHEINCUNK 2/29/96
Team Ver Packung Silicone Oil III Muhlen Koppel 2 for Opthalmic Ascheberg-Trentrade, Use (Sterile) Germany, Federal Rep. of
HONG KONG
Asia Unlimited The Shealy RelaxMate (aka RelaxEase) Hong Kong 86H0Y FEI #3002165857 8/27/98
Automatic Manufacturing Ltd. (Mfr) Shealy Relaxmate Kiwuntong, Hong Kong Glasses MID# HKAUTMANKIW 5/6/94
Azad International (HK) Limited WhisperXL mini sound II 33 Canton Road amplifier (behind the ear TRW 1, Room 2103 hearing aid) Kowloon, Hong Kong 12/21/94
Doo Jung H.K. Limited Pap Smear Brushes (may be II 21-D Broadway shipped as cosmetic brushes 12/F Mei Foo Sun Chuen or may be brush head only. Laichikok, Kowloon 6/8/93 Hong Kong ID#: HKDOOJUN21LAI
INDIA
International Medical Devices Freeman Universal III 17 Industrial Estate, Palam Rd. Intraocular Lenses Bombay, India (IOL) Anterior Chamber (Optional posterior chamber Style Code: IMD-AC-FA 7/6/92
Shah & Shah Intraocular Intraocular Lenses III Lens (Pvt) Ltd. 86HQL 2 Russell Street 4/10/95 H.D. Road, Joka 743512 Calcutta 700 071, India MID: INSHASHA743CAL FEI: 1000327725
ISRAEL
Zer Science Ltd. HIV I+II 57Y-99 Jerusalem, Israel One-Step Test Class III FEI #3000168281 7/9/98
NOTE:
Several FDA districts have encountered shipments of unapproved HIV diagnostic test kits invoiced and labeled for "research use only" or "investigational use only", and some of the kits were unlabeled.
HIV diagnostic test kits are Class III devices within the meaning of Sec. 513(f)(1) of the Act and are regulated by CBER under the current Intercenter Agreement between CDRH and CBER.
Investigations by FDA revealed that the unapproved HIV diagnostic test kits were intended for commercial distribution, not for "research" or "investigational" uses as invoiced. The unapproved diagnostic test kits claim to detect HIV antibodies in blood or saliva and provide results in the home in 15 minutes or less. The test kits could present a serious hazard to the public health, including possible HIV transmission to partners and delayed access to medical care due to misdiagnosed false negativetests.
Districts encountering shipments of the unapproved HIV diagnostic test kits should contact the CBER Import/Exp ort Team at (301) 827-6201.
ITALY
M.E.D.I.Co Italia Pacemaker (Phymos ADV/VDD-M) III Medical Electronic Devices (12/08/92) International Co. Via Pitagora, 15-35030 Rubano (PD) Italy MID# ITMEDELEISRUB
S.M.E.I.srl Sculpture Ultrasonic Aspiration Device (Surgical Medical Aesthetic (Sculpture Ultrasound Wave Liposculpture) Supplies) Via F. Negri 15 Product Code: 85MGI 15033 Cassale Monferrato 1/22/99 Alessandria, Italy FEI #3001811866
JAPAN
Fuji Latex Co., Ltd. Wrinkle Chapeau Condoms II 19-1, 3-Chome (7/20/93) Kanda Nishiki-Cho, Chiyoda-Ku Tokyo, Japan ID# JPFULAT191CHI
Fuji Medical Instruments "New Health Club" III Mfg. Co., Ltd. Low Frequency 5-521 Nipponbashi Therapeutic Apparatus Naniwa-Ku, Osaka, Japan Type C, Model HC-32 MID# JPFUJMED5521OSA (8/13/93)
Hirayama Manufacturing Corp. Sterilizer, autoclave 2-16-16 Yushima, Bunkyo-Ku 75LXG Tokyo 113 9/17/98 Japan FEI# 1000197696
Kyoto Daiichi Ammonia Checker II III Kagaku Co., Ltd Blood Ammonia Checker System 57 Nishi Aketa-cho Model AA-4120 (9/9/92) Higashi Kujo Minami Ku Kyoto 601, Japan
Maramunji Sangyo Co., LTD Infant Heel Warmers 17-11-3 Ishimaru Infant Crib Warmers Mino-Shi 12/27/94 Osaka 562, Japan
Nippon Germanium Laboratory Co., Ltd. Germanium Pellets 2-11-9 Kasuga, Shizuoka City Bandages III Shizuoka, Japan 5/20/96 MID# JPNIPGER2119SHT FEI# 1000548833
Sanwa Health Co. Ltd Germa Knee Sports Wrap III 39 Kamisekerya-sho Germa Adhesive Bandages III Murasakamo, Kita-Ka Kyoto, Japan
KOREA
Hesung Medical Supply Scalp Vein Sets II 517-4 Sangdaewon-Dong Infusion Sets II Seongnam City, Seoul, Korea
Unis Medical Electronics Heparin Lock (PRN) II Co., Ltd. Protected Needle II Rm. 508, Dae Kwang Bldg 7-15 Adapter (PNA) Nonhyun-Dong, Xangnam-Ku IV In-Line Connector II Seoul, Korea Multiple Sample Luer II Adapter ID# KRUNIMED715SEO (3/5/93)
MALAYSIA
Alang Bidara Industries Latex Patient I Sdn Bhd, Lot 2574, Examination Gloves Kampong Olak Lempit 80LYY, 80FMC Kuala Langat 9/4/96 42700 Banting, Selangor Darul Ehsan, West Malaysia FEI# 1000565458 MID# MYALABID2574KUA
L.S. Rubber SDN. BHD Flavored Latex Condoms Class II (previously known as MBF (All Flavors) Personal Care SDN. BHD) Product Code: 85LTZ PLO 22, Senai Industrial Estate 1/22/98 Phase 1, 81400 Senai Johor, Malaysia FEI#: 3001085209
MEXICO (MX)
DRA. Olga Z. de Kleiman Little Sentry Junior 175-101 Cuernavaca Infant Breathing Monitor Col. Condesa, Mexico City, 73FLS Mexico 6/29/00 FEI # 3002589842
MONACO (MC)
1-Minute-Test Ltd HIV 1/2 Whole Blood Test Kit 13 Bd Princess Charlotte 82[][][], 57Y[][]99 Monte Carlo, Monaco 98000 11/9/99 FEI # 3002848460
NETHERLANDS (NL) :
PAKISTON (PK)
Gogi Enterprises Circumcision Clamps P.O. Box 1367 85H- - FX Sialkot, Pakistan 5/17/00 FEI # 1000627636
Dar Expo P.O. Box 356 Fatima Jinnah Rd. Small Industries Estate Sialkot, Pakistan FEI # 3001348390
SINGAPORE (SG)
Genelabs Diagnostics PTE LTD Helico Blot 2.0; 83LYR 85 Science Park Drive, #04-01, HEV IgM ELISA; 83--- & The Cavendish, OraScreen HIV Rapid Singapore Science Park Test Kits; 57YY99 Singapore 8/13/97 FEI #1000436598
SOUTH AFRICA (ZA)
Anytestkits HIV 2 blood test kit Sunnyside 82- - - , 57YY99 Republic of South Africa 5/25/00 FEI # 3003016880
Note: HIV diagnostic test kits are Class III devices within the meaning of Section 513(f)(1) of the Act and are regulated by CBER under the current intercenter agreement between CDRH and CBER. The unapproved diagnostic test kits claimto detect HIV antibodies in blood or saliva and provide results in the home in 15 minutes or less.
The test kits are imported into the U.S. through the mail and may be entered as Asamples@ or for Apersonal use@. Thecontents may be labeled Afor investigational use@, for Aresearch use@, or Afor export only.@ The test kits could present a serious hazard to the public health, including possible HIV transmission to partners and delayed access to medical care due tomis-diagnosed false negative tests. If entries are encountered, contact CBER Import/Export Team at 301-827-62 01.
Ageless HIV 1/2, HIV 2 subtype O, Box 29054 serum, plasma or whole blood Sunnyside test kit 0132 Republic of South Africa (aka HIV/AIDS home test kit) FEI# 3003010115 82[][][], 57Y[][]99 1/29/01
M A Meyer HIV 1/2, HIV 2 subtype O, Box 29054 serum, plasma or whole blood Sunnyside test kit 0132 Republic of South Africa (aka HIV/AIDS home test kit) FEI# 3003010115 82[][][], 57Y[][]99 1/29/01
Sallamander Concepts HIV 1/2, HIV 2 subtype O, Box 29054 serum, plasma or whole blood Sunnyside test kit 0132 Republic of South Africa (aka HIV/AIDS home test kit) FEI# 3003134155 82[][][], 57Y[][]99 1/29/01
Note: HIV diagnostic test kits are Class III devices within the meaning of Section 513(f)(1) of the Act and a re regulated by CBER. The unapproved diagnostic test kits claim to detect HIV antibodies in blood or saliva and provide results in the home in 15 minutes or less.
The test kits are imported into the U.S. through the mail and may be entered as "test kit," "samples" or for " personal use." The contents may be labeled "for investigational use," for "research use," or "for export only." The test kits co uld present a serious hazard to the public health, including possible HIV transmission to partners and delayed access to medical care due to misdiagnosed false negative tests. If entries are encountered, contact CBER Import/Export Team at (301) 827-6201.
SWEDEN (SE)
Lic Care, AB BD5000 Optima Birthing Bed (10/27/92) II Svetsarvagen 20 BD6000 Optima Birthing Bed (10/27/92) II Solna, Sweden
Postal Address: LIC Care, AB 5-17183 Solna, Sweden or LIC Rehab Care AB Box 8164 S-163 08 SPANGA, Sweden
Scandicare Products AB All devices Depagaten 2, Box 34 Product codes: 85HFW, 79HXD S-33400 Anderstorp, Sweden 11/21/95 FEI# 6891 MID# SESCAPRO24AND
SWITZERLAND
Bilimed AG Belimed Washing Machine Model SM 700 Ch-5608 (3/5/92) III Stetton Belimed Scope Washing Machine Model Switzerland SME 2000 (3/5/92) III Belimed Washington Machine Model SM 1000 (3/5/92) III
Compex, S.A. Compex 2 Iontophoresis (Product Code=89EGJ) Chemin Du Devent 3/1/99 CH-1024 Ecublens Switzerland FEI# 3002601983
Corange International Ltd. Elecsys HBsAg Hamilton Cham Branch Immunoassay Kits Hinterbergstrasse 9, 11/26/97 Postbach 5146 PRODUCT CODE Cham, Switzerland 6330 83L[][]OM FEI#1000326892
HAMO AG Endoclean 2000, and Decontaminating II Reinigungs-Hyglenetechnik Machines Models LS-850, LS-76, DW/T-216 Bielstrasse 76 (1/30/92) 2542 Pieterlen/Biel Switzerland
Minimally Invasive Products, GmbH Orbasone TM, aka Kreuzlingen, Switzerland Orbasone Therapeutic Vibrator) FEI # 3003046204 and Ossanol TM, aka (Ossanol Therapeutic Vibrator) 89IRO - 6/29/00
TAIWAN, ROC ACUTE IDEA CO., LTD. Pacifier Thermometer TAIWAN, R.O.C. 3/9/94
Distributed by: ^
^ Trade Name: Paci-Temp ^
^ Trade Name: Lumiscope Baby Therm
WINTEK MICROCIRCUIT CORP. Pacifier Thermometer Taipei, Taiwan, R.O.C. 3/9/94
Distributed by:
^
^ Trade Name: Dubby
^
^ Trade Name: Lumiscope Baby Therm
TAIWAN SHINING YOUNG TRADING Pacifier Thermometer Co., Ltd. Taipei, Taiwan R.O.C. 3/9/94 Trade Name: Knoble
Distributed by: ^
^ Trade Name: Lumiscope Baby Therm
Chipper-Tech Co. Brainwave Synchronizer No. 19 Lane 53 Shwanglien St. 9/9/94 Taipei, Taiwan
Importer/Consignee: ^ ^
or ^ ^
Kung's Medical Instruments LYM -03-Terminator Mini Electrical III Company, Ltd. Syringe Needle Destroyer (2/1/93) P.O. Box 55-1620 Taipei, Taiwan, ROC
T.A. Yu Chanc Industrial Co., Ltd. Sun Eeze (fitsrite) 299 Nan Yang Road protective eye wear Seng Yaun, Taiwan ROC (10/14/94)
UNITED KINGDOM
Medical Wire & Equipment Co. Transwabs (MW169C, (Bath) Ltd. MW172PT, MW172CT, Corsham, Wiltshire, England MW174P, MW175C) UK SN13 9RT Theater Pack, Virocult, MID# UKMEDWIRCOR Chlamydia Transwab, Strip tests (Beta, Pro-, Pyo, Gram, and Indo-Test), Micro Ring (XV, AC, AN, and Yeast ID) 1/13/95
Copyrighted By Angels United On TMJ!
Can not be placed on any other web site or any support groups without:
the written permission of ANGELS UNITED ON TMJ!
"COPYRIGHT Feb. 2001" By Angels United On TMJ!
ANGELS UNITED IS UN-COVERING THE TRUTH ON TMJ!
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WE ARE ANGELS UNITED ON TMJ!
TMJD_SAFE_HAVEN_4_LIFE_ISSUES ยท TMJ SUPPORT GROUP
This TMJD Support Group is intended to be a Safe Haven and provide a place where people with TMJ pain can come and offer and receive support from people who know what they are going through. This is not a medical group and we do not have medical degrees or medical backgrounds. However, with the variety of members in here, there is bound to be someone who has been there and done that and can answer your questions.
This group is in memory of Debbie Ward whom suffered from TMJD & died of unknown causes.
There are many types of members with TMJD. Some have been treated medically, some treated with various splint therapies and physical therapies as well as some with surgical treatments ranging from Arthroscopy to full jaw joint replacements. Everyone with any degree of TMJD or has a family member that deals with it is welcome to join and offer and receive support that we all so badly need to get through each day with the pain we have to live with.
It is YOUR place to cry, scream or vent on the pain you are dealing with and how it is affecting your life and the lives of your loved ones. The group is MODERATED to avoid the unsolicited advertisements and spam. We are all in pain and do not need to have to deal with that too.
TMJ SURGERY FAMILY!.
A Great Place to Share Information! This site is for sharing and is not a substitute for the advise of your physician/oral surgeon. Please consult with your health care professional.
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