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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Holder, Head, Neurosurgical (Skull Clamp)
510(k) Number K142238
Device Name MAYFIELD Skull Clamp
Applicant
INTEGRA LIFESCIENCES CORPORATION
311 ENTERPRISE DR.
PLAINSBORO,  NJ  08536
Applicant Contact Brian Hoy
Correspondent
INTEGRA LIFESCIENCES CORPORATION
311 ENTERPRISE DR.
PLAINSBORO,  NJ  08536
Correspondent Contact Brian Hoy
Regulation Number882.4460
Classification Product Code
HBL  
Date Received08/13/2014
Decision Date 11/24/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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