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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 K110509
Device Name EVERYWAY INTERFERNTIAL STIMULATOR, MODEL IF-908
Applicant
EVERYWAY MEDICAL INSTRUMENTS CO., LTD.
845 ARONSON LAKE COURT
ROSWELL,  GA  30075
Applicant Contact JAY MANSOUR
Correspondent
EVERYWAY MEDICAL INSTRUMENTS CO., LTD.
845 ARONSON LAKE COURT
ROSWELL,  GA  30075
Correspondent Contact JAY MANSOUR
Regulation Number882.5890
Classification Product Code
LIH  
Date Received02/22/2011
Decision Date 06/20/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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