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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
Predetermined Change
Control Plan Authorized		 No
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