K043539 is an FDA 510(k) clearance for the DEMETECH STERILE SYNTHETIC ABSORBABLE SUTURES (PGA) AND NEEDLES, a Suture, Absorbable, Synthetic, Polyglycolic Acid (Class II — Special Controls, product code GAM), submitted by Demetech Corp. (Apollo Beach, US). The FDA issued a Cleared decision on April 6, 2005, 105 days after receiving the submission on December 22, 2004. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4493.
| 510(k) Number | K043539 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | December 22, 2004 |
| Decision Date | April 06, 2005 |
| Days to Decision | 105 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | GAM — Suture, Absorbable, Synthetic, Polyglycolic Acid |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 878.4493 |