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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 K030946
Device Name HEMCON BANDAGE OTC; HEMCON CATH/AID
Applicant
Hemcon, Inc.
10575 SW Cascade Ave.
Suite 130
Tigard,  OR  97223
Applicant Contact JAMES F HENSEL
Correspondent
Hemcon, Inc.
10575 SW Cascade Ave.
Suite 130
Tigard,  OR  97223
Correspondent Contact JAMES F HENSEL
Classification Product Code
QSY  
Date Received03/26/2003
Decision Date 06/19/2003
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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