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FDA 510(k) Application Details - K172354
Device Classification Name
Plate, Bone
More FDA Info for this Device
510(K) Number
K172354
Device Name
Plate, Bone
Applicant
Osstem Implant Co., Ltd..
66-16, Bansong-ro 513beon-gil, Haeundae-gu
Busan 612-070 KR
Other 510(k) Applications for this Company
Contact
Jungmin Yoo
Other 510(k) Applications for this Contact
Regulation Number
872.4760
More FDA Info for this Regulation Number
Classification Product Code
JEY
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
08/03/2017
Decision Date
03/26/2018
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
DE - Dental
Review Advisory Committee
DE - Dental
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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