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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 K853633
Device Name TENS CONDUCTIVE MEDIA PAD
Applicant
Alternative Design Systems, Inc.
419 Hackensack Ave.
Carlstadt,  NJ  07072
Applicant Contact JOHN L ESSMYER
Correspondent
Alternative Design Systems, Inc.
419 Hackensack Ave.
Carlstadt,  NJ  07072
Correspondent Contact JOHN L ESSMYER
Regulation Number882.1320
Classification Product Code
GXY  
Date Received08/30/1985
Decision Date 12/03/1985
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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