The following data is part of a De Novo classification by Tepha, Inc. with the FDA for Tephaflex Absorbable Suture.
| DeNovo ID | DEN060003 |
| Device Name: | TEPHAFLEX ABSORBABLE SUTURE |
| Classification | Suture, Recombinant Technology |
| Applicant | TEPHA, INC. 840 Memorial Drive Cambridge, MA 02139 |
| Contact | Mary P Legraw |
| Product Code | NWJ |
| CFR Regulation Number | 878.4494 [🔎] |
| Decision | Granted (DENG) |
| 510(k) Premarket Notification | K052225 |
| Review Advisory Board | General & Plastic Surgery |
| Classification Advisory | General & Plastic Surgery |
| Type | Post-NSE |
| Date Received | 2006-05-12 |
| Decision Date | 2007-02-08 |
| Reclassification Order: | Reclassification Order |