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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrode, Needle
510(k) Number K933795
Device Name CONCENTRIC EMG NEEDLE 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 Number882.1350
Classification Product Code
GXZ  
Date Received08/04/1993
Decision Date 04/22/1994
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
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