OSTEON, OSTEON SINUS, OSTEON LIFTING

Bone Grafting Material, Synthetic

GENOSS CO., LTD.

The following data is part of a premarket notification filed by Genoss Co., Ltd. with the FDA for Osteon, Osteon Sinus, Osteon Lifting.

Pre-market Notification Details

Device IDK102015
510k NumberK102015
Device Name:OSTEON, OSTEON SINUS, OSTEON LIFTING
ClassificationBone Grafting Material, Synthetic
Applicant GENOSS CO., LTD. 11075 KNOTT AVE., SUITE A Cypress,  CA  90630
ContactEunkyung Son
CorrespondentEunkyung Son
GENOSS CO., LTD. 11075 KNOTT AVE., SUITE A Cypress,  CA  90630
Product CodeLYC  
CFR Regulation Number872.3930 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2010-07-16
Decision Date2010-11-19
Summary:summary

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