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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name electromyograph, diagnostic
510(k) Number K102610
Device Name FOCUS EMG DEVICE
Applicant
TELEEMG, LLC USA
65 ARLINGTON ROAD
WOBURN,  MA  01801
Applicant Contact JOE F JABRE, M.D.
Correspondent
TELEEMG, LLC USA
65 ARLINGTON ROAD
WOBURN,  MA  01801
Correspondent Contact JOE F JABRE, M.D.
Regulation Number890.1375
Classification Product Code
IKN  
Subsequent Product Code
JXE  
Date Received09/10/2010
Decision Date 03/04/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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