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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 K072486
Device Name MODIFICATION TO HEMCON BANDAGE AND HEMCON BANDAGE OTC
Applicant
HEMCON MEDICAL TECHNOLOGIES, INC.
10575 SW CASCADE AVENUE
SUITE 130
PORTLAND,  OR  97223 -4363
Applicant Contact KEVIN HAWKINS
Correspondent
HEMCON MEDICAL TECHNOLOGIES, INC.
10575 SW CASCADE AVENUE
SUITE 130
PORTLAND,  OR  97223 -4363
Correspondent Contact KEVIN HAWKINS
Classification Product Code
QSY  
Date Received09/04/2007
Decision Date 08/06/2008
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product Yes
Recalls CDRH Recalls
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