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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 K992843
Device Name THE MAYFIELD / ACCISS SYSTEM WITH WINDOWS NT FOR CRANIAL SURGERY, THE MAYFIELD / OPTICAL ACCISS SYSTEM WITH WINDOWS NT F
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 Received08/24/1999
Decision Date 11/02/1999
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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