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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 K933803
Device Name DISPOSABLE TAB ELECTRODE
Applicant
Cadwell Laboratories, Inc.
909 N Kellogg St.
Kennewick,  WA  99336
Applicant Contact CARLTON M CADWELL
Correspondent
Cadwell Laboratories, Inc.
909 N Kellogg St.
Kennewick,  WA  99336
Correspondent Contact CARLTON M CADWELL
Regulation Number882.1320
Classification Product Code
GXY  
Date Received08/04/1993
Decision Date 07/08/1994
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
Recalls CDRH Recalls
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