Product code NAD
- Device name
- Dressing, Wound, Occlusive
- Medical specialty
- General, Plastic Surgery
- Device class
- 1
- Regulation number
- 878.4020
- Review panel
- SU
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Ineligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K254246 | LT Antibacterial Foam with Silver Dressing | Zhejiang Longterm Medical Technology Co., Ltd. | 2026-09-10 |
| K102403 | SAM CHEST SEAL WITH VAVLE; SAM CHEST SEAL | Sam Medical Products | 2011-03-03 |
| K091133 | APLION TOPICAL CARE SYSTEM | Aplion Medical,Llc | 2009-05-20 |
| K072560 | ENVELA (HYDROHESIVE OCCLUSIVE DRESSING) | Teikoku Pharma USA, Inc. | 2008-06-17 |
| K080524 | CENTURION SORBAVIEW OTC | Tri-State Hospital Supply Corp. | 2008-04-23 |
| K060046 | DERMASTREAM | Enzysurge , Ltd. | 2006-02-27 |
| K020781 | WET CHAMBER | Kinetic Concepts, Inc. | 2002-05-06 |
| K990530 | KERLIX MD ANTIMICROBIAL GAUZE DRESSING | The Kendall Company, L.P. | 2000-01-31 |
| K990861 | WOUND DRESSING/ABD PAD, MODEL #10810 | Hospital Specialty Co. | 1999-04-12 |
| K964534 | OTOSILK OTOLOGICAL GRAFT DRESSING | Boston Medical Products, Inc. | 1997-04-09 |
| K960815 | DUPAD, DUPAD W/ABDOM. PAD, DUMEX ABDOM. PAD, COMBO DRESSING ROLL/COMBINE DRESSING ROLL | Dumex Medical Surgical Products, Ltd. | 1996-04-29 |
| K955863 | ALLDRESS MULTI LAYERED WOUND DRESSING | Molnlycke/Scott Health Care | 1996-03-13 |
| K952203 | OTOSILK | Boston Medical Products, Inc. | 1995-07-31 |
| K930697 | MEDLINE STERILE GAUZE SPONGES | Medline Industries, Inc. | 1993-06-24 |
| K912022 | FRASTEC DRYNET, BRIDAL VEIL, VARIOUS SIZES | Fraass Survival Systems, Inc. | 1991-08-02 |
| K905519 | MONTROSE DRESSING APPLICATORS | Olemunda Pty , Ltd. | 1991-03-06 |
| K901853 | MODIFIED LABELING FOR BIOCLUSIVE* TRANS FILM DRESS | Johnson & Johnson Medical, Inc. | 1991-01-28 |
| K901378 | TENSOPLUS LITE | Smith & Nephew United, Inc. | 1990-06-12 |
| K897156 | HYDRASORB(TM) | Avitar, Inc. | 1990-02-21 |
| K895654 | SORBEX(TM) SOFT SPONGE | Fountain Pharmaceuticals, Inc. | 1990-02-20 |
| K895817 | HERMAL WOUND CARE KIT | Stiefel Research Institute, Inc. | 1990-01-19 |
| K895845 | 2018 ARTERIAL/VENOUS PRESSURE DRESSING | Advance Medical Designs, Inc. | 1989-11-01 |
| K894254 | HYPAFIX DRESSING RETENTION SHEET | Smith & Nephew United, Inc. | 1989-08-31 |
| K892837 | STERIL-DERM TRANSPARENT WOUND DRESSING | Biointerface Technologies, Inc. | 1989-08-01 |
| K891998 | BANDAGE, MUSLIN, COMPRESSED, CAMOUFLAGED, 37X37X52 | Elwyn Industries | 1989-06-05 |
| K891459 | STERILE BURNNET PRE-CUT (VARIOUS SIZES) | Western Medical, Ltd. | 1989-05-26 |
| K882558 | AREOLA/NIPPLE DRESSING | Cooper Surgical/Aesthete | 1989-05-24 |
| K890603 | BEAM TECH WOUND DRESSING* | Beam Tech , Ltd. | 1989-05-23 |
| K892527 | DUODERM* TRANSPARENT HYDROCOLLOID DRESSING-MODIFY | Convatec, A Division of E.R. Squibb & Sons | 1989-05-11 |
| K884791 | PERME-AID TRANSPARENT DRESSING, #11XX | Nitto Denko Technical Corp. | 1989-05-04 |
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