K043330 is an FDA 510(k) clearance for the POLYPROPILENE SURGICAL SUTURES, a Suture, Nonabsorbable, Synthetic, Polypropylene (Class II — Special Controls, product code GAW), submitted by Demetech Corp. (Apollo Beach, US). The FDA issued a Cleared decision on May 16, 2005, 165 days after receiving the submission on December 2, 2004. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.5010.
| 510(k) Number | K043330 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | December 02, 2004 |
| Decision Date | May 16, 2005 |
| Days to Decision | 165 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | GAW — Suture, Nonabsorbable, Synthetic, Polypropylene |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 878.5010 |