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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 K083190
Device Name D-STAT DRY WRAP HEMOSTATIC BANDAGE, MODEL: 3015
Applicant
Vascular Solutions, Inc.
6464 Sycamore Court
Minneapolis,  MN  55369
Applicant Contact LISA GALLATIN
Correspondent
Vascular Solutions, Inc.
6464 Sycamore Court
Minneapolis,  MN  55369
Correspondent Contact LISA GALLATIN
Classification Product Code
QSX  
Date Received10/29/2008
Decision Date 11/12/2008
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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