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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 Ct. N.
Minneapolis,  MN  55369
Applicant Contact LISA GALLATIN
Correspondent
Vascular Solutions, Inc.
6464 Sycamore Ct. N.
Minneapolis,  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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