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510(k) K110926

BONE PLATE; BONE SCREW by Biomaterials Korea, Inc. — Product Code JEY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 8, 2011
Date Received
April 1, 2011
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Plate, Bone
Device Class
Class II
Regulation Number
872.4760
Review Panel
DE
Submission Type

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