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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 K051440
Device Name MAYFIELD INFINITY SKULL CLAMP
Applicant
INTEGRA LIFESCIENCES CORP.
311C ENTERPRISE DRIVE
PLAINSBORO,  NJ  08536
Applicant Contact DONNA R WALLACE
Correspondent
INTEGRA LIFESCIENCES CORP.
311C ENTERPRISE DRIVE
PLAINSBORO,  NJ  08536
Correspondent Contact DONNA R WALLACE
Regulation Number882.4460
Classification Product Code
HBL  
Date Received06/02/2005
Decision Date 09/20/2005
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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