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510(k) K050319

MAYFIELD MR/CT SKULL CLAMP, MODEL 4-0-A-1104 by Integra Lifesciences Corp. — Product Code HBL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 31, 2005
Date Received
February 9, 2005
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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