K002550 is an FDA 510(k) clearance for the RDH BANDAGE, a Bandage, Liquid (Class I — General Controls, product code KMF), submitted by Marine Polymer Technologies, Inc. (Danvers, US). The FDA issued a Cleared decision on December 20, 2000, 125 days after receiving the submission on August 17, 2000. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 880.5090.
| 510(k) Number | K002550 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | August 17, 2000 |
| Decision Date | December 20, 2000 |
| Days to Decision | 125 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 |