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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
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