K963656 is an FDA 510(k) clearance for the FOAM CALCIUM ALIGINATE TOPICAL WOUND DRESSING, a Bandage, Liquid (Class I — General Controls, product code KMF), submitted by Adri (Park Forest, US). The FDA issued a Cleared decision on November 12, 1996, 61 days after receiving the submission on September 12, 1996. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 880.5090.
| 510(k) Number | K963656 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | September 12, 1996 |
| Decision Date | November 12, 1996 |
| Days to Decision | 61 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 |