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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 Without Thrombin Or Other Biologics
510(k) Number K965034
Device Name SORBASTACE
Applicant
Hemostace, LLC
15825 Shady Grove Rd.,
Suite 90
Rockville,  MD  20850
Applicant Contact DAVID WEST
Correspondent
Hemostace, LLC
15825 Shady Grove Rd.,
Suite 90
Rockville,  MD  20850
Correspondent Contact DAVID WEST
Classification Product Code
QSY  
Date Received12/17/1996
Decision Date 04/09/1998
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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