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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 K900200
Device Name COOK STEREOTAXIC GUIDE
Applicant
Cook, Inc.
P.O.Box 2402
West Lafayette,  IN  47906
Applicant Contact FEARNOT, PHD
Correspondent
Cook, Inc.
P.O.Box 2402
West Lafayette,  IN  47906
Correspondent Contact FEARNOT, PHD
Regulation Number882.4560
Classification Product Code
HAW  
Date Received01/16/1990
Decision Date 05/31/1990
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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