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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 K003457
Device Name UNIGRAFT
Applicant
UNICARE BIOMEDICAL
25951 LA CUESTA AVE.
LAGUNA HILLS,  CA  92653
Applicant Contact STAN YANG
Correspondent
UNICARE BIOMEDICAL
25951 LA CUESTA AVE.
LAGUNA HILLS,  CA  92653
Correspondent Contact STAN YANG
Regulation Number872.3930
Classification Product Code
LYC  
Date Received11/07/2000
Decision Date 01/09/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
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