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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 K112716
Device Name OSTEON II
Original Applicant
1f gyeonggi r&d center
906-5 iui-dong
suwon-si yeongtong-gu, gyeongg,  KR 443-270
Original Contact sungwon lee
Regulation Number872.3930
Classification Product Code
Date Received09/19/2011
Decision Date 01/17/2012
Decision substantially equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No