K023029 is an FDA 510(k) clearance for the DEMETECH SILK NONABSORBABLE SUTURE, a Suture, Nonabsorbable, Silk (Class II — Special Controls, product code GAP), submitted by Demetech Corp. (Miami, US). The FDA issued a Cleared decision on November 25, 2002, 75 days after receiving the submission on September 11, 2002. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.5030.
| 510(k) Number | K023029 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | September 11, 2002 |
| Decision Date | November 25, 2002 |
| Days to Decision | 75 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | GAP — Suture, Nonabsorbable, Silk |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 878.5030 |