The following data is part of a premarket notification filed by Tepha, Inc. with the FDA for Tephaflex Composite Mesh.
| Device ID | K101287 |
| 510k Number | K101287 |
| Device Name: | TEPHAFLEX COMPOSITE MESH |
| Classification | Mesh, Surgical, Absorbable, Abdominal Hernia |
| Applicant | TEPHA, INC. 99 HAYDEN AVENUE, SUITE 360 Lexington, MA 02421 |
| Contact | Mary P Legraw |
| Correspondent | Mary P Legraw TEPHA, INC. 99 HAYDEN AVENUE, SUITE 360 Lexington, MA 02421 |
| Product Code | OWT |
| Subsequent Product Code | OOD |
| Subsequent Product Code | OTO |
| Subsequent Product Code | OXL |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-05-07 |
| Decision Date | 2010-08-30 |
| Summary: | summary |