Device Classification Name |
hemostatic wound dressing with thrombin or other biologics
|
510(k) Number |
K063860 |
Device Name |
THROMBIGEL THROMBIN/GELATIN FOAM HEMOSTAT |
Applicant |
VASCULAR SOLUTIONS, INC. |
6464 SYCAMORE COURT |
MINNEAPOLIS,
MN
55369
|
|
Applicant Contact |
JAMES CHAPMAN |
Correspondent |
VASCULAR SOLUTIONS, INC. |
6464 SYCAMORE COURT |
MINNEAPOLIS,
MN
55369
|
|
Correspondent Contact |
JAMES CHAPMAN |
Classification Product Code |
|
Date Received | 12/28/2006 |
Decision Date | 02/13/2007 |
Decision |
Substantially Equivalent
(SESE) |
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
Yes
|