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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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