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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 K121177
Device Name BOND APATITE
Applicant
AUGMA BIOMATERIALS, LTD.
11234 EL CAMINO REAL
SUITE 200
san diego,  CA  92130
Applicant Contact kevin a thomas
Correspondent
AUGMA BIOMATERIALS, LTD.
11234 EL CAMINO REAL
SUITE 200
san diego,  CA  92130
Correspondent Contact kevin a thomas
Regulation Number872.3930
Classification Product Code
LYC  
Date Received04/18/2012
Decision Date 12/05/2013
Decision substantially equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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