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FDA 510(k) Application Details - K140037
Device Classification Name
Plate, Bone
More FDA Info for this Device
510(K) Number
K140037
Device Name
Plate, Bone
Applicant
OSTEONIC CO., LTD.
505 3 Ho Digital-ro 29-gil, Guro-gu
Seoul 152-779 KR
Other 510(k) Applications for this Company
Contact
Priscilla Chung
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
01/07/2014
Decision Date
01/20/2015
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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