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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Electrical, Evoked Response
510(k) Number K932994
Device Name EVOKED POTENTIAL SYSTEM-1.0
Applicant
Neuromedical Systems, Inc.
12101 County Line Rd.
Chesterland,  OH  44026
Applicant Contact CHARLES MANNING
Correspondent
Neuromedical Systems, Inc.
12101 County Line Rd.
Chesterland,  OH  44026
Correspondent Contact CHARLES MANNING
Regulation Number882.1870
Classification Product Code
GWF  
Date Received06/18/1993
Decision Date 04/15/1996
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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