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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Oral Wound Dressing
510(k) Number K090612
Device Name BENACEL
Applicant
Unicare Biomedical
22971 Triton Way
Laguna Hills,  CA  92653
Applicant Contact STAN YANG
Correspondent
Unicare Biomedical
22971 Triton Way
Laguna Hills,  CA  92653
Correspondent Contact STAN YANG
Classification Product Code
OLR  
Date Received03/06/2009
Decision Date 07/24/2009
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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