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510(k) K943071

THE TITANIUM FIXATION SYSTEM by Biomedics — Product Code JEY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 6, 1995
Date Received
June 28, 1994
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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