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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 K843464
Device Name SIEGEN NEUROSCOPE
Applicant
SIEGEN CORP.
2450 BAYSHORE FRONTAGE ROAD
MOUNTAIN VIEW,  CA  94043 -
Applicant Contact CAPERS W MCDONALD
Correspondent
SIEGEN CORP.
2450 BAYSHORE FRONTAGE ROAD
MOUNTAIN VIEW,  CA  94043 -
Correspondent Contact CAPERS W MCDONALD
Regulation Number882.1870
Classification Product Code
GWF  
Date Received09/05/1984
Decision Date 11/20/1984
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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