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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 K941815
Device Name ISOTRON III
Applicant
EXCEL TECH. LTD.
2892 PORTLAND DR.
OAKVILLE,ONTARIO,  CA L6H 5W8
Applicant Contact JOHN R MUMFORD
Correspondent
EXCEL TECH. LTD.
2892 PORTLAND DR.
OAKVILLE,ONTARIO,  CA L6H 5W8
Correspondent Contact JOHN R MUMFORD
Regulation Number882.5890
Classification Product Code
LIH  
Subsequent Product Codes
GZK   IPF  
Date Received04/12/1994
Decision Date 05/03/1995
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
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