K894802 is an FDA 510(k) clearance for the AWC BUTTERFLY WOUND CLOSURES. This device is classified as a Strip, Adhesive, Closure, Skin (Class I - General Controls, product code FPX).
Submitted by American White Cross, Inc. (New Rochelle, US). The FDA issued a Cleared decision on January 31, 1990, 187 days after receiving the submission on July 28, 1989.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 880.5240.
| 510(k) Number | K894802 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 28, 1989 |
| Decision Date | January 31, 1990 |
| Days to Decision | 187 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | — |
| Product Code | FPX — Strip, Adhesive, Closure, Skin |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 880.5240 |