The following data is part of a premarket notification filed by Tepha, Inc. with the FDA for Surgilattice Scaffold.
| Device ID | K202425 |
| 510k Number | K202425 |
| Device Name: | SurgiLattice Scaffold |
| Classification | Surgical Film |
| Applicant | Tepha, Inc. 99 Hayden Avenue, Suite 360 Lexington, MA 02421 |
| Contact | Kavetha Ram |
| Correspondent | Connie Garrison 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 | 2020-08-25 |
| Decision Date | 2021-08-19 |