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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 K050319
Device Name MAYFIELD MR/CT SKULL CLAMP, MODEL 4-0-A-1104
Applicant
Integra Lifesciences Corp.
4900 Charlemar Dr., Bldg. A
Cincinnati,  OH  45227
Applicant Contact CHARLES E DINKLER II
Correspondent
Integra Lifesciences Corp.
4900 Charlemar Dr., Bldg. A
Cincinnati,  OH  45227
Correspondent Contact CHARLES E DINKLER II
Regulation Number882.4460
Classification Product Code
HBL  
Date Received02/09/2005
Decision Date 03/31/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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