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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name electrode, cutaneous
510(k) Number K890981
Device Name ELECTRO-TOUCH (ET) GLOVE
Original Applicant
PSYCHOENERGETIC SYSTEMS, INC.
392 marple rd.
broomall,  PA  19008
Original Contact stephen r berlant
Regulation Number882.1320
Classification Product Code
GXY  
Date Received02/27/1989
Decision Date 10/19/1989
Decision substantially equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
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