The following data is part of a premarket notification filed by Synovis Micro Companies Alliance, Inc. with the FDA for Gem Biover Microvascular Clamps.
| Device ID | K221843 |
| 510k Number | K221843 |
| Device Name: | GEM Biover Microvascular Clamps |
| Classification | Clamp, Vascular |
| Applicant | Synovis Micro Companies Alliance, Inc. (a Subsidiary Of Baxter International, Inc.) 439 Industrial Lane Birmingham, AL 35211 |
| Contact | Julie Carlston |
| Correspondent | Julie Carlston Synovis Micro Companies Alliance, Inc. (a Subsidiary Of Baxter International, Inc.) 439 Industrial Lane Birmingham, AL 35211 |
| Product Code | DXC |
| CFR Regulation Number | 870.4450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-06-24 |
| Decision Date | 2022-09-14 |