K946321 is an FDA 510(k) clearance for the BIOSTRIP STERILE WOUND CLOSURE STRIP, a Strip, Adhesive, Closure, Skin (Class I — General Controls, product code FPX), submitted by Cornelia Damsky, Inc. (Stamford, US). The FDA issued a Cleared decision on January 12, 1995, 15 days after receiving the submission on December 28, 1994. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 880.5240.
| 510(k) Number | K946321 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | December 28, 1994 |
| Decision Date | January 12, 1995 |
| Days to Decision | 15 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | FPX — Strip, Adhesive, Closure, Skin |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 880.5240 |