510(k) Premarket Notification

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Device Classification Name Stimulator, Nerve, Transcutaneous, for Pain Relief
510(k) Number K896948
Regulation Number 882.5890

 

Device Name ALPHA-STIM CS
Applicant ELECTROMEDICAL PRODUCTS, INC.
Contact L Kirsch
Classification Product Code GZJ
Date Received 12/13/1989
Decision Date 02/23/1990
Decision Substantially equivalent (SE)
Classification Advisory Committee
Neurology
Review Advisory Committee Neurology
Statement/Summary/Purged Status Purged, no summary or statement
Type Traditional
Reviewed by Third Party No