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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 K150916
Device Name HemCon Bandage PRO, HemCon Patch PRO, HemCon Strip PRO, HemCon Strip First Aid PRO, ChitoFlex PRO
Applicant
Hem Con Medical Technologies, Inc.
720 SW Washington St., Suite 200
Portland,  OR  97225
Applicant Contact Jody Oyama
Correspondent
Hem Con Medical Technologies, Inc.
720 SW Washington St., Suite 200
Portland,  OR  97225
Correspondent Contact Jody Oyama
Classification Product Code
QSY  
Subsequent Product Code
LYA  
Date Received04/06/2015
Decision Date 11/10/2015
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Clinical Trials NCT00716365
NCT00863356
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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