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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 K932860
Device Name MAYFIELD ADULT DISPOSABLE SKULL PIN
Applicant
Ohio Medical Instrument Co., Inc.
3924 Virginia Ave.
Cincinnati,  OH  45227
Applicant Contact DENNIS LACKEY
Correspondent
Ohio Medical Instrument Co., Inc.
3924 Virginia Ave.
Cincinnati,  OH  45227
Correspondent Contact DENNIS LACKEY
Regulation Number882.4460
Classification Product Code
HBL  
Date Received06/11/1993
Decision Date 09/28/1993
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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