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 | K190499 |
510k Number | K190499 |
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 | 2019-03-01 |
Decision Date | 2019-09-06 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
10844735006176 | K190499 | 000 |