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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 K080532
Device Name BENACEL, MODELS C-001, C-002 AND C-005
Applicant
Unicare Biomedical, Inc.
22971-B Triton Way
Laguna Hills,  CA  92653
Applicant Contact STAN YANG
Correspondent
Unicare Biomedical, Inc.
22971-B Triton Way
Laguna Hills,  CA  92653
Correspondent Contact STAN YANG
Classification Product Code
QSY  
Date Received02/26/2008
Decision Date 11/12/2008
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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