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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 K120633
Device Name MAYFIELD SKULL CLAMP
Applicant
Integra LifeSciences Corporation
311 Enterprise Dr.
Planisboro,  NJ  08536
Applicant Contact LINDSAY MIGNONE
Correspondent
Integra LifeSciences Corporation
311 Enterprise Dr.
Planisboro,  NJ  08536
Correspondent Contact LINDSAY MIGNONE
Regulation Number882.4460
Classification Product Code
HBL  
Date Received03/01/2012
Decision Date 05/24/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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