The following data is part of a premarket notification filed by Biom'up Sas with the FDA for Covaortho-nerve Resorbable Collagen Membrane.
| Device ID | K103081 |
| 510k Number | K103081 |
| Device Name: | COVAORTHO-NERVE RESORBABLE COLLAGEN MEMBRANE |
| Classification | Cuff, Nerve |
| 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 | JXI |
| CFR Regulation Number | 882.5275 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-10-19 |
| Decision Date | 2012-03-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03760193182590 | K103081 | 000 |
| 03760193182026 | K103081 | 000 |
| 03760193182033 | K103081 | 000 |
| 03760193182040 | K103081 | 000 |
| 03760193182057 | K103081 | 000 |
| 03760193182552 | K103081 | 000 |
| 03760193182569 | K103081 | 000 |
| 03760193182576 | K103081 | 000 |
| 03760193182583 | K103081 | 000 |
| 03760193182019 | K103081 | 000 |