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510(k) K130309

RAPIDFLAP LS CRANIAL FLAP FIXATION SYSTEM by Biomet Microfixation — Product Code GXR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 17, 2013
Date Received
February 7, 2013
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cover, Burr Hole
Device Class
Class II
Regulation Number
882.5250
Review Panel
NE
Submission Type

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