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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 K072208
Device Name MAYFIELD DISPOSABLE AND REUSABLE TITANIUM SKULL PINS
Applicant
Integra Lifesciences Corporation
311 Enterprise Dr.
Planisboro,  NJ  08536
Applicant Contact HELDER A SOUSA
Correspondent
Integra Lifesciences Corporation
311 Enterprise Dr.
Planisboro,  NJ  08536
Correspondent Contact HELDER A SOUSA
Regulation Number882.4460
Classification Product Code
HBL  
Date Received08/08/2007
Decision Date 09/07/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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