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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Biofeedback
510(k) Number K935853
Device Name EMG TRAINER
Applicant
Unitech
702 N. Blackhawk Ave.
Madison,  WI  53705
Applicant Contact PAUL HOOPER
Correspondent
Unitech
702 N. Blackhawk Ave.
Madison,  WI  53705
Correspondent Contact PAUL HOOPER
Regulation Number882.5050
Classification Product Code
HCC  
Date Received12/08/1993
Decision Date 01/18/1995
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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