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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 K122240
Device Name BONE PLUS BCP EAGLE EYE
Original Applicant
MEGAGEN IMPLANT CO., LTD
325 n puente st. unit b
brea,  CA  92821
Original Contact april lee
Regulation Number872.3930
Classification Product Code
LYC  
Date Received07/27/2012
Decision Date 08/21/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Dental
Review Advisory Committee Dental
summary summary
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
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