K023030 is an FDA 510(k) clearance for the DEMETECH POLYESTER NONABSORBABLE SUTURE, a Suture, Nonabsorbable, Synthetic, Polyethylene (Class II — Special Controls, product code GAT), submitted by Demetech Corp. (Miami, US). The FDA issued a Cleared decision on June 18, 2003, 280 days after receiving the submission on September 11, 2002. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.5000.
| 510(k) Number | K023030 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | September 11, 2002 |
| Decision Date | June 18, 2003 |
| Days to Decision | 280 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | GAT — Suture, Nonabsorbable, Synthetic, Polyethylene |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 878.5000 |