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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 K153582
Device Name Prometheus ChitoGauze XR PRO
Applicant
Hem Con Medical Technologies, Inc.
720 SW Washington St.
Suite 200
Portland,  OR  97205
Applicant Contact Maire Ni Beilliu
Correspondent
Hem Con Medical Technologies, Inc.
720 SW Washington St.
Suite 200
Portland,  OR  97205
Correspondent Contact Maire Ni Beilliu
Classification Product Code
QSY  
Date Received12/15/2015
Decision Date 05/25/2016
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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