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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name hemostatic wound dressing with thrombin or other biologics
510(k) Number K030836
Device Name D-STAT-DRY HEMOSTATIC BANDAGE; D-STAT RADIAL HEMOSTATIC BANDAGE
Applicant
VASCULAR SOLUTIONS, INC.
2495 XENIUM LN. NORTH
MINNEAPOLIS,  MN  55441
Applicant Contact DEBORAH JENSEN
Correspondent
VASCULAR SOLUTIONS, INC.
2495 XENIUM LN. NORTH
MINNEAPOLIS,  MN  55441
Correspondent Contact DEBORAH JENSEN
Classification Product Code
QSX  
Date Received03/17/2003
Decision Date 09/17/2003
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product Yes
Recalls CDRH Recalls
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