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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Media, Electroconductive
510(k) Number K904889
Device Name TENS CONDUCTIVE MEDIA PAD
Applicant
Creative Design Systems, Inc.
421 Hackensack St.
Carlstadt,  NJ  07072
Applicant Contact JOHN L ESSMYER
Correspondent
Creative Design Systems, Inc.
421 Hackensack St.
Carlstadt,  NJ  07072
Correspondent Contact JOHN L ESSMYER
Regulation Number882.1275
Classification Product Code
GYB  
Date Received10/22/1990
Decision Date 05/14/1991
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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