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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 K042481
Device Name POLARIS PRESSURE ADJUSTABLE VALVE SYSTEM, MODELS SPV-140, SPV-300, SPV-400
Applicant
SOPHYSA SA
70 WALNUT ST.
WELLESLEY,  MA  02481
Applicant Contact JACKIE MASSE
Correspondent
SOPHYSA SA
70 WALNUT ST.
WELLESLEY,  MA  02481
Correspondent Contact JACKIE MASSE
Regulation Number882.5550
Classification Product Code
JXG  
Date Received09/13/2004
Decision Date 12/14/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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