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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 Pl.
Goleta,  CA  93117
Applicant Contact STEPHEN W LAGUETTE
Correspondent
Clinical Neuro Systems, LLC
870 Serenidad Pl.
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
Predetermined Change
Control Plan Authorized
No
Recalls CDRH Recalls
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