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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 K981934
Device Name THE BAGNOLI-4 EMG SYSTEM
Applicant
Delsys, Inc.
P.O. Box 15734
Boston,  MA  02215
Applicant Contact GIANLUCA DE LUCA
Correspondent
Delsys, Inc.
P.O. Box 15734
Boston,  MA  02215
Correspondent Contact GIANLUCA DE LUCA
Regulation Number882.5050
Classification Product Code
HCC  
Date Received06/02/1998
Decision Date 08/31/1998
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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