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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 K141227
Device Name POLARIS PRESSURE ADJUSTABLE VALVE SYSTEM/POLARIS ADJUSTABLE VALVE WITH SIPHONX
Applicant
SOPHYSA SA
25108 MARGUERITE PARKWAY, SUITE A-354
MISSION VIEJO,  CA  92692
Applicant Contact GUSTAVO KOBRIN
Correspondent
SOPHYSA SA
25108 MARGUERITE PARKWAY, SUITE A-354
MISSION VIEJO,  CA  92692
Correspondent Contact GUSTAVO KOBRIN
Regulation Number882.5550
Classification Product Code
JXG  
Date Received05/12/2014
Decision Date 04/02/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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