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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bone Grafting Material, Synthetic
510(k) Number K092567
Device Name MODIFICATION TO UNIGRAFT
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
Regulation Number872.3930
Classification Product Code
LYC  
Date Received08/20/2009
Decision Date 11/25/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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