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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name stimulator, nerve, transcutaneous, for pain relief
510(k) Number K901417
Device Name ELECTROSTIM MST
Applicant
PROMATEK INDUSTRIES, LTD.
8390 MAYRAND, MONTREAL
QUEBEC, H4P 2C9,  CA
Applicant Contact ARTHUR LEVINE
Correspondent
PROMATEK INDUSTRIES, LTD.
8390 MAYRAND, MONTREAL
QUEBEC, H4P 2C9,  CA
Correspondent Contact ARTHUR LEVINE
Regulation Number882.5890
Classification Product Code
GZJ  
Date Received03/26/1990
Decision Date 08/28/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
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