K992537 is an FDA 510(k) clearance for the PERI-STRIPS-SLEEVE, PERI-STRIPS-STRIP AND PERI-STRIPS DRY (NON-NAOH-TREATED AND NAOH-TREATED. This device is classified as a Mesh, Surgical (Class II — Special Controls, product code FTM).
Submitted by Bio-Vascular, Inc. (St. Paul, US). The FDA issued a Cleared decision on February 22, 2000, 208 days after receiving the submission on July 29, 1999.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.3300.
| 510(k) Number | K992537 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | July 29, 1999 |
| Decision Date | February 22, 2000 |
| Days to Decision | 208 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | FTM — Mesh, Surgical |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 878.3300 |