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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 K073264
Device Name D-STAT DRY CLEAR HEMOSTATIC BANDAGE, MODEL 3005
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 Received11/20/2007
Decision Date 12/07/2007
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
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