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510(k) K133437

1ST MTP PLATE by Osteomed — Product Code HRS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 2, 2013
Date Received
November 7, 2013
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Plate, Fixation, Bone
Device Class
Class II
Regulation Number
888.3030
Review Panel
OR
Submission Type

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