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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 K823675
Device Name FRONING GUIDANCE SYSTEM #TX-8200
Applicant
Today'S Machining & Design, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Today'S Machining & Design, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number882.4560
Classification Product Code
HAW  
Date Received12/07/1982
Decision Date 01/05/1983
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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