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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 K933799
Device Name TEN-20 CONDUCTIVE PASTE GEL
Applicant
CADWELL LABORATORIES, INC.
909 NORTH KELLOGG ST.
KENNEWICK,  WA  99336
Applicant Contact CARLTON M CADWELL
Correspondent
CADWELL LABORATORIES, INC.
909 NORTH KELLOGG ST.
KENNEWICK,  WA  99336
Correspondent Contact CARLTON M CADWELL
Regulation Number882.1275
Classification Product Code
GYB  
Date Received08/04/1993
Decision Date 05/27/1994
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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