510(k) K973036
- Device
- 3M TEGADERM TRANSPARENT DRESSING, 3M TEGADERM TRANSPARENT DRESSING (FIRST AID DELIVERY), 3M TEGADERM HP TRANSPARENT DRES
- Applicant
- 3M HEALTH CARE
- 510(k) number
- K973036
- Product code
- MGP
- Decision
- Substantially Equivalent For Some Indications (SN)
- Decision date
- 1997-11-12
- Date received
- 1997-08-14
- Regulation
- 510(k) Premarket Notification
- Classification name
- Dressing, Wound And Burn, Occlusive
- Medical specialty
- 510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration Follow FDA En Español Search FDA Home Food Drugs Medical Devices
- Review panel
- General & Plastic Surgery
- Device class
- U
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- KAREN C HOLMEN
- Address
- P.O. Box 33275 3m Center, 275-3e-08 St. Paul MN US 55144 55144
FDA Registration Numbers#
- 9680091
- 3030733800
- 3003636207
- 3031168520
- 1223925
- 1219313
- 1320894
- 3014562978
- 3012502601
- 3010034780
- 3010419931
- 1644312
- 3005941719
- 3011137372
- 3012494290
- 3012421607
- 3013557562
- 1526534
- 3005012805
- 3010041511
- 3004365956
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code MGP #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K012995 | COLLATEK SHEET | Biocore Medical Technologies, Inc. | 2001-10-25 |
| K012997 | COLLATEK FOAM | Biocore Medical Technologies, Inc. | 2001-10-25 |
| K001508 | LASERSKIN DRESSING | Fidia Advanced Biopolymers Srl | 2001-07-25 |
| K990079 | FASTSEAL CHEST WOUND DRESSING | Greenfield Medical Technologies, Inc. | 1999-12-23 |
| K991214 | SIMPLICARE TRANSPARENT WOUND DRESSING | Hollister, Inc. | 1999-10-14 |
| K992302 | DERMAPHYLYX SKIN PROTECTORS, PROTECT IT SKIN PROTECTORS | Dermaphylyx, Inc. | 1999-09-14 |
| K992005 | GILTECH PLUS TRANSPARENT DRESSING | Giltech Plus, Inc. | 1999-09-03 |
| K990875 | DERMAPHYLYX FILM WOUND DRESSING AND HEALIAN FILM WOUND DRESSING | Dermaphylyx, Inc. | 1999-05-27 |
| K990438 | DERMAFLEX WOUND DRESSING, DERMAFLEX FOAM WOUND DRESSING, HEALIAFLEX WOUND DRESSING, HEALIAFOAM WOUND DRESSING | Dermaphylyx, Inc. | 1999-03-25 |
| K984371 | MEPITEL NON ADHERENT SILICONE DRESSING | Molnlycke Health Care, Inc. | 1999-03-03 |
| K983303 | INNOVATIVE TECHNOLOGIES HYDROCOLLOID AND INTELLIGENT HYDROCOLLOID WOUND DRESSINGS | Innovative Technologies , Ltd. | 1998-12-09 |
| K983234 | TIELLE PLUS HYDROPOLYMER ADHESIVE DRESSING | Johnson & Johnson Medical, Div. of Ethicon, Inc. | 1998-11-25 |
| K983394 | MODIFICATION TO TIELLE HYDROPOLMER DRESSING | Johnson & Johnson Medical, Div. of Ethicon, Inc. | 1998-11-03 |
| K983184 | MEPILEX | Molnlycke Health Care, Inc. | 1998-10-28 |
| K974891 | ACUTEK'S HYDROCOLLOID WOUND DRESSING, TIB 197013 | Acutek Adhesive Specialties, Inc. | 1998-10-21 |
Legacy Summary#
summary
FDA Review#
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