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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Neurological Stereotaxic Instrument
510(k) Number K991267
Device Name SPINE APPLICATIONS FOR THE MAYFIELD/ACCISS OPERATING ARM AND OPTICAL ACCISS SYSTEMS MODULE, MAYFIELD/ACCISS SPINE RING A
Applicant
Ohio Medical Instrument Co., Inc.
4900 Charlemar Dr.
Cincinnati,  OH  45227
Applicant Contact KENNETH B MILLER
Correspondent
Ohio Medical Instrument Co., Inc.
4900 Charlemar Dr.
Cincinnati,  OH  45227
Correspondent Contact KENNETH B MILLER
Regulation Number882.4560
Classification Product Code
HAW  
Date Received04/13/1999
Decision Date 07/12/1999
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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