Device Classification Name |
hemostatic wound dressing with thrombin or other biologics
|
510(k) Number |
K033709 |
Device Name |
VASCULAR SOLUTIONS D-STAT 2 DRY HEMOSTATIC BANDAGE |
Applicant |
VASCULAR SOLUTIONS, INC. |
6464 SYCAMORE COURT |
MINNEAPOLIS,
MN
55369
|
|
Applicant Contact |
GREGORY W SACHS |
Correspondent |
VASCULAR SOLUTIONS, INC. |
6464 SYCAMORE COURT |
MINNEAPOLIS,
MN
55369
|
|
Correspondent Contact |
GREGORY W SACHS |
Classification Product Code |
|
Date Received | 11/26/2003 |
Decision Date | 12/18/2003 |
Decision |
Substantially Equivalent
(SESE) |
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
Yes
|
Recalls |
CDRH Recalls
|