DEN060003 is an FDA 510(k) submission for the TEPHAFLEX ABSORBABLE SUTURE. This device is classified as a Suture, Recombinant Technology (Class II - Special Controls, product code NWJ).
Submitted by Tepha, Inc. (Cambridge, US). The FDA issued a Not Cleared (DENG) decision on February 8, 2007.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4494. Intended For Use In Soft Tissue Approximation. Indicated For Use In General Soft Tissue Approximation And/or Ligation..
| 510(k) Number | DEN060003 FDA.gov |
| FDA Decision | Not Cleared Not Substantially Equivalent (DENG) |
| Date Received | May 12, 2006 |
| Decision Date | February 08, 2007 |
| Days to Decision | 272 days |
| Submission Type | Post-NSE |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | - |
| Product Code | NWJ - Suture, Recombinant Technology |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4494 |
| Definition | Intended For Use In Soft Tissue Approximation. Indicated For Use In General Soft Tissue Approximation And/or Ligation. |