The following data is part of a premarket notification filed by Biover Ag with the FDA for Biover.
| Device ID | K011208 |
| 510k Number | K011208 |
| Device Name: | BIOVER |
| Classification | Clamp, Vascular |
| Applicant | BIOVER AG 252 W. RIDLEY AVE. Ridley Park, PA 19078 |
| Contact | Heinz E Wick |
| Correspondent | Heinz E Wick BIOVER AG 252 W. RIDLEY AVE. Ridley Park, PA 19078 |
| Product Code | DXC |
| CFR Regulation Number | 870.4450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-04-19 |
| Decision Date | 2002-10-02 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 7640174510276 | K011208 | 000 |
| 7640174510030 | K011208 | 000 |
| 7640174510054 | K011208 | 000 |
| 07640174510061 | K011208 | 000 |
| 07640174510085 | K011208 | 000 |
| 07640174510108 | K011208 | 000 |
| 07640174510122 | K011208 | 000 |
| 07640174510146 | K011208 | 000 |
| 7640174510177 | K011208 | 000 |
| 07640174510184 | K011208 | 000 |
| 7640174510214 | K011208 | 000 |
| 07640174510221 | K011208 | 000 |
| 07640174510245 | K011208 | 000 |
| 07640174510009 | K011208 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() BIOVER 78724152 3246346 Live/Registered |
Biover AG 2005-09-30 |