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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 K921954
Device Name ISOTRON III
Applicant
Excel Tech. , Ltd.
2892 Portland Dr.
Oakville,Ontario,  CA L6H 5W8
Applicant Contact JOHN MUMFORD
Correspondent
Excel Tech. , Ltd.
2892 Portland Dr.
Oakville,Ontario,  CA L6H 5W8
Correspondent Contact JOHN MUMFORD
Regulation Number882.5890
Classification Product Code
LIH  
Date Received04/27/1992
Decision Date 08/26/1992
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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