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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 K023298
Device Name HEMCON BANDAGE
Applicant
Hemcon, Inc.
10575 SW Cascade Ave., Suite 130
Portland,  OR  97223
Applicant Contact JAMES F HENSEL
Correspondent
Hemcon, Inc.
10575 SW Cascade Ave., Suite 130
Portland,  OR  97223
Correspondent Contact JAMES F HENSEL
Classification Product Code
QSY  
Date Received10/03/2002
Decision Date 11/04/2002
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Expedited Review Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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