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 | K132727 |
| 510k Number | K132727 |
| Device Name: | GEM FLOW COUPLER DEVICE AND SYSTEM |
| Classification | Device, Anastomotic, Microvascular |
| Applicant | SYNOVIS LIFE TECHNOLOGIES, INC. 2575 UNIVERSITY AVE., STE.180 St. Paul, MN 55114 -1024 |
| Contact | Troy Thome |
| Correspondent | Troy Thome SYNOVIS LIFE TECHNOLOGIES, INC. 2575 UNIVERSITY AVE., STE.180 St. Paul, MN 55114 -1024 |
| Product Code | MVR |
| CFR Regulation Number | 878.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-09-03 |
| Decision Date | 2013-10-22 |
| Summary: | summary |