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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 K081183
Device Name WOUNDSTAT
Applicant
Traumacure, Inc.
2001 Pennsylvania Ave.
Suite 950
Washington,  DC  20006
Applicant Contact CAMPBELL HUTTON
Correspondent
Traumacure, Inc.
2001 Pennsylvania Ave.
Suite 950
Washington,  DC  20006
Correspondent Contact CAMPBELL HUTTON
Classification Product Code
QSY  
Date Received04/25/2008
Decision Date 06/19/2008
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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