K972914 is an FDA 510(k) clearance for the SYVEK PATCH, a Tape And Bandage, Adhesive (Class I — General Controls, product code KGX), submitted by Marine Polymer Technologies, Inc. (Danvers, US). The FDA issued a Cleared decision on December 22, 1997, 137 days after receiving the submission on August 7, 1997. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 880.5240.
| 510(k) Number | K972914 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | August 07, 1997 |
| Decision Date | December 22, 1997 |
| Days to Decision | 137 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Statement |
| Product Code | KGX — Tape And Bandage, Adhesive |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 880.5240 |