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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name interferential current therapy
510(k) Number K873566
Device Name ELECTROSTIM I.F.
Applicant
PROMATEK INDUSTRIES, LTD.
8390 MAYRAND, MONTREAL
QUEBEC, H4P 2C9,  CA
Applicant Contact ART LEVINE
Correspondent
PROMATEK INDUSTRIES, LTD.
8390 MAYRAND, MONTREAL
QUEBEC, H4P 2C9,  CA
Correspondent Contact ART LEVINE
Regulation Number882.5890
Classification Product Code
LIH  
Date Received09/02/1987
Decision Date 02/01/1988
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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