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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 K993654
Device Name NEUROCOMP
Applicant
Neurocybernetics
55 Northern Blvd., Suite 200
Great Neck,  NY  11021
Applicant Contact SUSAN D GOLDSTEIN-FALK
Correspondent
Neurocybernetics
55 Northern Blvd., Suite 200
Great Neck,  NY  11021
Correspondent Contact SUSAN D GOLDSTEIN-FALK
Regulation Number882.5050
Classification Product Code
HCC  
Subsequent Product Code
GWQ  
Date Received10/29/1999
Decision Date 01/27/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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