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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 K150963
Device Name AnsCare ChitoClot Pad
Applicant
Benq Materials Corporation
29 Jianguo E. Rd., Guishan
Taoyuan,  TW 33341
Applicant Contact Kenix Chang
Correspondent
Benq Materials Corporation
29 Jianguo E. Rd., Guishan
Taoyuan,  TW 33341
Correspondent Contact Kenix Chang
Classification Product Code
QSY  
Date Received04/10/2015
Decision Date 11/05/2015
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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