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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name device, biofeedback
510(k) Number K013399
Device Name MODEL MES-9000/EMG SYSTEM
Applicant
MYOTRONICS-NOROMED, INC.
15425 53RD AVE. SOUTH
TUKWILA,  WA  98188
Applicant Contact FRAY ADIB
Correspondent
MYOTRONICS-NOROMED, INC.
15425 53RD AVE. SOUTH
TUKWILA,  WA  98188
Correspondent Contact FRAY ADIB
Regulation Number882.5050
Classification Product Code
HCC  
Date Received10/15/2001
Decision Date 11/13/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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