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FDA 510(k) Application Details - K122240
Device Classification Name
Bone Grafting Material, Synthetic
More FDA Info for this Device
510(K) Number
K122240
Device Name
Bone Grafting Material, Synthetic
Applicant
MEGAGEN IMPLANT CO., LTD
325 N PUENTE ST. UNIT B
BREA, CA 92821 US
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Contact
APRIL LEE
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Regulation Number
872.3930
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Classification Product Code
LYC
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More FDA Info for this Product Code
Date Received
07/27/2012
Decision Date
08/21/2012
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
DE - Dental
Review Advisory Committee
DE - Dental
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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