The following data is part of a premarket notification filed by Biom'up Sas with the FDA for Covamax Resorbable Collagen Membrane.
Device ID | K103087 |
510k Number | K103087 |
Device Name: | COVAMAX RESORBABLE COLLAGEN MEMBRANE |
Classification | Barrier, Animal Source, Intraoral |
Applicant | BIOM'UP SAS 8, ALLEE IRENE JOLIOT-CURIE St-priest, FR 69800 |
Contact | Valerie Centis |
Correspondent | Valerie Centis BIOM'UP SAS 8, ALLEE IRENE JOLIOT-CURIE St-priest, FR 69800 |
Product Code | NPL |
CFR Regulation Number | 872.3930 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2010-10-19 |
Decision Date | 2011-08-26 |
Summary: | summary |