K033762 is an FDA 510(k) clearance for the SERRALAPG, a Suture, Absorbable, Synthetic, Polyglycolic Acid (Class II — Special Controls, product code GAM), submitted by Serral, S.A. DE C.V. (Williamsburg, US). The FDA issued a Cleared decision on March 15, 2004, 104 days after receiving the submission on December 2, 2003. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4493.
| 510(k) Number | K033762 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | December 02, 2003 |
| Decision Date | March 15, 2004 |
| Days to Decision | 104 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Statement |
| Product Code | GAM — Suture, Absorbable, Synthetic, Polyglycolic Acid |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 878.4493 |