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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 K102015
Device Name OSTEON, OSTEON SINUS, OSTEON LIFTING
Applicant
GENOSS CO., LTD.
11075 KNOTT AVE., SUITE A
CYPRESS,  CA  90630
Applicant Contact EUNKYUNG SON
Correspondent
GENOSS CO., LTD.
11075 KNOTT AVE., SUITE A
CYPRESS,  CA  90630
Correspondent Contact EUNKYUNG SON
Regulation Number872.3930
Classification Product Code
LYC  
Date Received07/16/2010
Decision Date 11/19/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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