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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 K940050
Device Name FOCUS EMG
Applicant
FASSTECH
155 MIDDLESEX TURNPIKE
BURLINGTON,  MA  01803
Applicant Contact LEE RICHARD BRODY
Correspondent
FASSTECH
155 MIDDLESEX TURNPIKE
BURLINGTON,  MA  01803
Correspondent Contact LEE RICHARD BRODY
Regulation Number882.5050
Classification Product Code
HCC  
Date Received01/05/1994
Decision Date 02/24/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
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