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510(k) K081401

MAYFIELD MR/X-RAY SKULL CLAMP by Integra Lifesciences Corp. — Product Code HBL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 8, 2008
Date Received
May 19, 2008
Clearance Type
Special
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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