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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 K934289
Device Name MAYFIELD RADIOLUCENT SKULL CLAMP
Applicant
Ohio Medical Instrument Co., Inc.
3924 Virginia Ave.
Cincinnati,  OH  45227
Applicant Contact DENNIS R LACKEY
Correspondent
Ohio Medical Instrument Co., Inc.
3924 Virginia Ave.
Cincinnati,  OH  45227
Correspondent Contact DENNIS R LACKEY
Regulation Number882.4460
Classification Product Code
HBL  
Date Received09/02/1993
Decision Date 01/07/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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