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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 K944615
Device Name A620 EEG
Applicant
Stoelting Co.
620 Wheat Ln.
Wood Dale,  IL  60191
Applicant Contact SAID EL-DINARY
Correspondent
Stoelting Co.
620 Wheat Ln.
Wood Dale,  IL  60191
Correspondent Contact SAID EL-DINARY
Regulation Number882.5050
Classification Product Code
HCC  
Date Received09/20/1994
Decision Date 09/18/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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