The following data is part of a premarket notification filed by Tepha, Inc. with the FDA for Tephaflex Light Mesh.
| Device ID | K113721 |
| 510k Number | K113721 |
| Device Name: | TEPHAFLEX LIGHT MESH |
| Classification | Surgical Film |
| 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 | OOD |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-12-19 |
| Decision Date | 2012-02-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00810054980636 | K113721 | 000 |
| 00810054980803 | K113721 | 000 |
| 00810054980810 | K113721 | 000 |
| 00810054980827 | K113721 | 000 |
| 00810054980544 | K113721 | 000 |
| 00810054980551 | K113721 | 000 |
| 00810054980568 | K113721 | 000 |
| 00810054980575 | K113721 | 000 |
| 00810054980582 | K113721 | 000 |
| 00810054980599 | K113721 | 000 |
| 00810054980605 | K113721 | 000 |
| 00810054980612 | K113721 | 000 |
| 00810054980629 | K113721 | 000 |
| 00810054980797 | K113721 | 000 |