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510(k) K142238

MAYFIELD Skull Clamp by Integra LifeSciences Corporation — Product Code HBL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 24, 2014
Date Received
August 13, 2014
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Holder, Head, Neurosurgical (Skull Clamp)
Device Class
Class II
Regulation Number
882.4460
Review Panel
NE
Submission Type

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