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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 K011983
Device Name INSIGHT GENESIS
Applicant
FASSTECH
155 MIDDLESEX TURNPIKE
BURLINGTON,  MA  01803
Applicant Contact LEE BRODY
Correspondent
FASSTECH
155 MIDDLESEX TURNPIKE
BURLINGTON,  MA  01803
Correspondent Contact LEE BRODY
Regulation Number882.5050
Classification Product Code
HCC  
Date Received06/26/2001
Decision Date 08/30/2001
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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