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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 K063860
Device Name THROMBIGEL THROMBIN/GELATIN FOAM HEMOSTAT
Applicant
Vascular Solutions, Inc.
6464 Sycamore Ct.
Minneapolis,  MN  55369
Applicant Contact JAMES CHAPMAN
Correspondent
Vascular Solutions, Inc.
6464 Sycamore Ct.
Minneapolis,  MN  55369
Correspondent Contact JAMES CHAPMAN
Classification Product Code
QSX  
Date Received12/28/2006
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
Predetermined Change
Control Plan Authorized		 No
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