OSTEON II


Device Classification Name

bone grafting material, synthetic

510(k) Number K112716
Device Name OSTEON II
Applicant
GENOSS CO., LTD.
1f gyeonggi r&d center
906-5 iui-dong
suwon-si yeongtong-gu, gyeongg, 

KR

443-270

Applicant Contact sungwon lee
Correspondent
GENOSS CO., LTD.
1f gyeonggi r&d center
906-5 iui-dong
suwon-si yeongtong-gu, gyeongg, 

KR

443-270

Correspodent Contact sungwon lee
Regulation Number 872.3930
Classification Product Code
LYC  
Date Received 09/19/2011
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