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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
Predetermined Change
Control Plan Authorized		 No
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