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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 K851659
Device Name SKULL MOUNTED STEREOTACTIC SURGICAL DEVICE
Applicant
Medco Products, Co., Inc.
96 Fair St.
Cooperstown,  NY  13326
Applicant Contact MARK CAROL
Correspondent
Medco Products, Co., Inc.
96 Fair St.
Cooperstown,  NY  13326
Correspondent Contact MARK CAROL
Regulation Number882.4560
Classification Product Code
HAW  
Date Received04/23/1985
Decision Date 07/01/1985
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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