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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 K033709
Device Name VASCULAR SOLUTIONS D-STAT 2 DRY HEMOSTATIC BANDAGE
Applicant
Vascular Solutions, Inc.
6464 Sycamore Ct.
Minneapolis,  MN  55369
Applicant Contact GREGORY W SACHS
Correspondent
Vascular Solutions, Inc.
6464 Sycamore Ct.
Minneapolis,  MN  55369
Correspondent Contact GREGORY W SACHS
Classification Product Code
QSX  
Date Received11/26/2003
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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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