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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
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