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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 K931428
Device Name CADWELL 6200 A
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 Number882.1870
Classification Product Code
GWF  
Date Received03/26/1993
Decision Date 06/22/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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