K072930 is an FDA 510(k) clearance for the DEMETECH ABSORBABLE SURGICAL SUTURE PLAIN & CHROMIC GUT, a Suture, Absorbable, Natural (Class II — Special Controls, product code GAL), submitted by Demetech Corp. (Miami, US). The FDA issued a Cleared decision on April 30, 2008, 197 days after receiving the submission on October 16, 2007. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4830.
| 510(k) Number | K072930 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | October 16, 2007 |
| Decision Date | April 30, 2008 |
| Days to Decision | 197 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | GAL — Suture, Absorbable, Natural |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 878.4830 |