K983519 is an FDA 510(k) clearance for the COMFEEL SEASORB DRESSING. This device is classified as a Bandage, Liquid (Class I - General Controls, product code KMF).
Submitted by Coloplast Corp. (Marietta, US). The FDA issued a Cleared decision on December 30, 1998, 83 days after receiving the submission on October 8, 1998.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 880.5090.
| 510(k) Number | K983519 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 08, 1998 |
| Decision Date | December 30, 1998 |
| Days to Decision | 83 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | KMF — Bandage, Liquid |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 880.5090 |