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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 K081401
Device Name MAYFIELD MR/X-RAY SKULL CLAMP
Applicant
INTEGRA LIFESCIENCES CORP.
311 ENTERPRISE DR.
PLAINSBORO,  NJ  08536
Applicant Contact HELDER A SOUSA
Correspondent
INTEGRA LIFESCIENCES CORP.
311 ENTERPRISE DR.
PLAINSBORO,  NJ  08536
Correspondent Contact HELDER A SOUSA
Regulation Number882.4460
Classification Product Code
HBL  
Date Received05/19/2008
Decision Date 10/08/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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