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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 K102212
Device Name D-STAT DRY SILVER; D-STAT DRY CLEAR SILVER; D-STAT DRY WRAP SILVER; THROMBIX SILVER
Applicant
Vascular Solutions, Inc.
6464 Sycamore Court N
Maple Grove,  MN  55369
Applicant Contact LISA GALLATIN
Correspondent
Vascular Solutions, Inc.
6464 Sycamore Court N
Maple Grove,  MN  55369
Correspondent Contact LISA GALLATIN
Classification Product Code
QSX  
Date Received08/06/2010
Decision Date 04/08/2011
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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