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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Electrical, Evoked Response
510(k) Number K811848
Device Name MODEL SIX BEAM SYSTEM
Applicant
Braintech, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Braintech, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number882.1870
Classification Product Code
GWF  
Date Received07/01/1981
Decision Date 09/08/1981
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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