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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 K915858
Device Name MYOTRAC2
Applicant
Thought Technology , Ltd.
2180 Belgrave Ave.
Montreal, Quebec,  CA H4A 2L8
Applicant Contact HAL K MYERS
Correspondent
Thought Technology , Ltd.
2180 Belgrave Ave.
Montreal, Quebec,  CA H4A 2L8
Correspondent Contact HAL K MYERS
Regulation Number882.5050
Classification Product Code
HCC  
Date Received12/27/1991
Decision Date 09/09/1992
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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