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 |