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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 K080818
Device Name HEMCON BANDAGE, HEMCON BANDAGE OTC, HEMCON CHITOFLEX-SURGICAL DRESSING
Applicant
Hem Con Medical Technologies, Inc.
10575 SW Cascade Ave., Suite 130
Portland,  OR  97223
Applicant Contact KEVIN HAWKINS
Correspondent
Hem Con Medical Technologies, Inc.
10575 SW Cascade Ave., Suite 130
Portland,  OR  97223
Correspondent Contact KEVIN HAWKINS
Classification Product Code
QSY  
Date Received03/24/2008
Decision Date 05/15/2008
Decision Substantially Equivalent (SESE)
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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