K963096 is an FDA 510(k) clearance for the ALLEVYN HYDRO POLY DRESSING ND ALL TRAC DRESSING. This device is classified as a Bandage, Liquid (Class I — General Controls, product code KMF).
Submitted by Smith & Nephew United, Inc. (Largo, US). The FDA issued a Cleared decision on October 25, 1996, 77 days after receiving the submission on August 9, 1996.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 880.5090.
| 510(k) Number | K963096 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | August 09, 1996 |
| Decision Date | October 25, 1996 |
| Days to Decision | 77 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Statement |
| Product Code | KMF — Bandage, Liquid |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 880.5090 |