K954857 is an FDA 510(k) clearance for the COMFEEL:ALGINATE FILLER. This device is classified as a Bandage, Liquid (Class I - General Controls, product code KMF).
Submitted by Coloplast Corp. (Fort Worth, US). The FDA issued a Cleared decision on November 14, 1995, 22 days after receiving the submission on October 23, 1995.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 880.5090.
| 510(k) Number | K954857 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - NSE Converted (SN) |
| Date Received | October 23, 1995 |
| Decision Date | November 14, 1995 |
| Days to Decision | 22 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | — |
| Product Code | KMF — Bandage, Liquid |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 880.5090 |