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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name shunt, central nervous system and components
510(k) Number K920156
Device Name CLINICAL NEURO SYST MONITORR EXT CSF DRAIN/MONI SY
Applicant
CLINICAL NEURO SYSTEMS LLC.
870 SERENIDAD PLACE
GOLETA,  CA  93117
Applicant Contact STEPHEN W LAGUETTE
Correspondent
CLINICAL NEURO SYSTEMS LLC.
870 SERENIDAD PLACE
GOLETA,  CA  93117
Correspondent Contact STEPHEN W LAGUETTE
Regulation Number882.5550
Classification Product Code
JXG  
Date Received01/14/1992
Decision Date 03/16/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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