The following data is part of a premarket notification filed by Tela Bio, Inc. with the FDA for Ovine Tissue Matrix(otm).
| Device ID | K141053 |
| 510k Number | K141053 |
| Device Name: | OVINE TISSUE MATRIX(OTM) |
| Classification | Mesh, Surgical |
| Applicant | TELA BIO, INC. 1 GREAT VALLEY PARKWAY, SUITE 24 Malven, PA 19355 |
| Contact | Donna Stauffer |
| Correspondent | Donna Stauffer TELA BIO, INC. 1 GREAT VALLEY PARKWAY, SUITE 24 Malven, PA 19355 |
| Product Code | FTM |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-04-24 |
| Decision Date | 2014-12-11 |
| Summary: | summary |