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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name electromyograph, diagnostic
510(k) Number K162383
Device Name Cadwell Sierra Summit, Cadwell Sierra Ascent
Applicant
CADWELL INDUSTRIES, INC.
909 NORTH KELLOGG STREET
KENNEWICK,  WA  99336
Applicant Contact CHRISTOPHER BOLKAN
Correspondent
CADWELL INDUSTRIES, INC.
909 NORTH KELLOGG STREET
KENNEWICK,  WA  99336
Correspondent Contact CHRISTOPHER BOLKAN
Regulation Number890.1375
Classification Product Code
IKN  
Subsequent Product Codes
GWE   GWF   GWJ   GZP   JXE  
Date Received08/25/2016
Decision Date 03/01/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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