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510(k) K032427

FEP FIXATION SYSTEM AND STYLO WRIST FIXATION SYSTEM by Meridan Medical — Product Code JEC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 9, 2003
Date Received
August 6, 2003
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Component, Traction, Invasive
Device Class
Class II
Regulation Number
888.3040
Review Panel
OR
Submission Type

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