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510(k) K130389

MAYFIELD INFINITY XR2 SKULL CLAMP by Integra LifeSciences Corporation — Product Code HBL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 23, 2013
Date Received
February 15, 2013
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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