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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Electrical, Evoked Response
510(k) Number K924723
Device Name CADWELL SIERRA
Applicant
CADWELL LABORATORIES, INC.
909 NORTH KELLOGG ST.
KENNEWICK,  WA  99336
Applicant Contact CALTON M CADWELL
Correspondent
CADWELL LABORATORIES, INC.
909 NORTH KELLOGG ST.
KENNEWICK,  WA  99336
Correspondent Contact CALTON M CADWELL
Regulation Number882.1870
Classification Product Code
GWF  
Date Received09/21/1992
Decision Date 03/23/1993
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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