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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name full-montage standard electroencephalograph
510(k) Number K883557
Device Name NEUROWAVE SYSTEM 2
Applicant
DURDEN ENTERPRISES, INC.
P.O. BOX 700
AUBURN,  GA  30203
Applicant Contact JOHN G DURDEN
Correspondent
DURDEN ENTERPRISES, INC.
P.O. BOX 700
AUBURN,  GA  30203
Correspondent Contact JOHN G DURDEN
Regulation Number882.1400
Classification Product Code
GWQ  
Date Received08/19/1988
Decision Date 12/16/1988
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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