K926587 is an FDA 510(k) clearance for the REVISED LABELING FOR NYLON SUTURE (POLYAMIDE), a Suture, Nonabsorbable, Synthetic, Polyamide (Class II — Special Controls, product code GAR), submitted by Look, Inc. (Ada, US). The FDA issued a Cleared decision on December 17, 1993, 381 days after receiving the submission on December 1, 1992. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.5020.
| 510(k) Number | K926587 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | December 01, 1992 |
| Decision Date | December 17, 1993 |
| Days to Decision | 381 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Statement |
| Product Code | GAR — Suture, Nonabsorbable, Synthetic, Polyamide |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 878.5020 |