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FDA 510(k) Application Details - K102015
Device Classification Name
Bone Grafting Material, Synthetic
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510(K) Number
K102015
Device Name
Bone Grafting Material, Synthetic
Applicant
GENOSS CO., LTD.
11075 KNOTT AVE., SUITE A
CYPRESS, CA 90630 US
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Contact
EUNKYUNG SON
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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
07/16/2010
Decision Date
11/19/2010
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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