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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 K953124
Device Name MAYFIELD RADIOLUCENT 2000 SKULL CLAMP
Applicant
OHIO MEDICAL INSTRUMENT CO., INC.
3924 VIRGINIA AVE.
CINCINNATI,  OH  45227
Applicant Contact F. WILLIAM SWEET
Correspondent
OHIO MEDICAL INSTRUMENT CO., INC.
3924 VIRGINIA AVE.
CINCINNATI,  OH  45227
Correspondent Contact F. WILLIAM SWEET
Regulation Number882.4460
Classification Product Code
HBL  
Date Received07/05/1995
Decision Date 02/09/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
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