Device Classification Name |
device, anastomotic, microvascular
|
510(k) Number |
K142309 |
Device Name |
GEM Flow COUPLER Device and System |
Applicant |
Synovis Life Technologies, Inc. |
2575 University Ave. West, Suite 180 |
St. Paul,
MN
55114
|
|
Applicant Contact |
Troy Thome |
Correspondent |
Synovis Life Technologies, Inc. |
2575 University Ave. West, Suite 180 |
St. Paul,
MN
55114
|
|
Correspondent Contact |
Troy Thome |
Regulation Number | 878.4300
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 08/19/2014 |
Decision Date | 09/16/2014 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|