NAD — Dressing, Wound, Occlusive Class I
FDA product code NAD covers "Dressing, Wound, Occlusive", a Class I medical device regulated under 21 CFR 878.4020. Submissions are reviewed by the General, Plastic Surgery panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- NAD
- Device Class
- Class I
- Regulation Number
- 878.4020
- Submission Type
- Review Panel
- SU
- Medical Specialty
- General, Plastic Surgery
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K102403 | sam medical products | SAM CHEST SEAL WITH VAVLE; SAM CHEST SEAL | March 3, 2011 |
| K091133 | aplion medical | APLION TOPICAL CARE SYSTEM | May 20, 2009 |
| K072560 | teikoku pharma usa | ENVELA (HYDROHESIVE OCCLUSIVE DRESSING) | June 17, 2008 |
| K080524 | tri-state hospital supply | CENTURION SORBAVIEW OTC | April 23, 2008 |
| K060046 | enzysurge | DERMASTREAM | February 27, 2006 |
| K043063 | oxyband technologies | OXYBAND WOUND DRESSING | March 24, 2005 |
| K020781 | kinetic concepts | WET CHAMBER | May 6, 2002 |
| K990530 | kendall company, l.p | KERLIX MD ANTIMICROBIAL GAUZE DRESSING | January 31, 2000 |
| K990861 | hospital specialty | WOUND DRESSING/ABD PAD, MODEL #10810 | April 12, 1999 |
| K964534 | boston medical products | OTOSILK OTOLOGICAL GRAFT DRESSING | April 9, 1997 |
| K960815 | dumex medical surgical products | DUPAD, DUPAD W/ABDOM. PAD, DUMEX ABDOM. PAD, COMBO DRESSING ROLL/COMBINE DRESSIN | April 29, 1996 |
| K955863 | molnlycke/scott health care | ALLDRESS MULTI LAYERED WOUND DRESSING | March 13, 1996 |
| K952203 | boston medical products | OTOSILK | July 31, 1995 |
| K930697 | medline industries | MEDLINE STERILE GAUZE SPONGES | June 24, 1993 |
| K912022 | fraass survival systems | FRASTEC DRYNET, BRIDAL VEIL, VARIOUS SIZES | August 2, 1991 |
| K905519 | olemunda pty | MONTROSE DRESSING APPLICATORS | March 6, 1991 |
| K901853 | johnson and johnson medical | MODIFIED LABELING FOR BIOCLUSIVE* TRANS FILM DRESS | January 28, 1991 |
| K901378 | smith and nephew united | TENSOPLUS LITE | June 12, 1990 |
| K897156 | avitar | HYDRASORB(TM) | February 21, 1990 |
| K895654 | fountain pharmaceuticals | SORBEX(TM) SOFT SPONGE | February 20, 1990 |