K926586 is an FDA 510(k) clearance for the REVISED LABELING FOR CHROMIC AND PLAIN GUT SUTURES, a Suture, Absorbable, Natural (Class II — Special Controls, product code GAL), submitted by Look, Inc. (Ada, US). The FDA issued a Cleared decision on December 22, 1993, 386 days after receiving the submission on December 1, 1992. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4830.
| 510(k) Number | K926586 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | December 01, 1992 |
| Decision Date | December 22, 1993 |
| Days to Decision | 386 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Statement |
| Product Code | GAL — Suture, Absorbable, Natural |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 878.4830 |