The following data is part of a premarket notification filed by Synovis Life Technologies, Inc. with the FDA for Gem Flow Coupler Device And System.
| Device ID | K143589 |
| 510k Number | K143589 |
| Device Name: | GEM Flow COUPLER Device And System |
| Classification | Device, Anastomotic, Microvascular |
| Applicant | Synovis Life Technologies, Inc. 2575 University Ave. West, Suite 180 St. Paul, MN 55114 |
| Contact | Jodi Jorgenson |
| Correspondent | Jodi Jorgenson Synovis Life Technologies, Inc. 2575 University Ave. West, Suite 180 St. Paul, MN 55114 |
| Product Code | MVR |
| CFR Regulation Number | 878.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-12-18 |
| Decision Date | 2015-01-16 |
| Summary: | summary |