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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 K992465
Device Name SOPHY SU8 PRESSURE ADJUSTABLE VALVE
Applicant
SOPHYSA SA
70 WALNUT ST.
WELLESLEY,  MA  02481
Applicant Contact JACQUELINE MASSE
Correspondent
SOPHYSA SA
70 WALNUT ST.
WELLESLEY,  MA  02481
Correspondent Contact JACQUELINE MASSE
Regulation Number882.5550
Classification Product Code
JXG  
Date Received07/23/1999
Decision Date 09/21/2000
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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