The following data is part of a premarket notification filed by Baxter/ Synovis Micro Companies Alliance Inc. with the FDA for Gem Flowcoupler System.
| Device ID | K191252 |
| 510k Number | K191252 |
| Device Name: | Gem FlowCoupler System |
| Classification | Device, Anastomotic, Microvascular |
| Applicant | Baxter/ Synovis Micro Companies Alliance Inc. 2875 University Ave. West St. Paul, MN 55114 |
| Contact | Julie Carlston |
| Correspondent | Julie Carlston Baxter/ Synovis Micro Companies Alliance Inc. 2875 University Ave. West St. Paul, MN 55114 |
| Product Code | MVR |
| CFR Regulation Number | 878.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-05-09 |
| Decision Date | 2019-07-09 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00844735006155 | K191252 | 000 |
| 00844735006148 | K191252 | 000 |