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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 K033850
Device Name MEDTRONIC PS MEDICAL STRATA NSC VALVE AND SHUNT ASSEMBLIES WITH AND WITHOUT BIOGLIDE
Applicant
MEDTRONIC NEUROSURGERY
125 CREMONA DR.,
GOLETA,  CA  93117
Applicant Contact JEFFREY HENDERSON
Correspondent
MEDTRONIC NEUROSURGERY
125 CREMONA DR.,
GOLETA,  CA  93117
Correspondent Contact JEFFREY HENDERSON
Regulation Number882.5550
Classification Product Code
JXG  
Date Received12/11/2003
Decision Date 01/13/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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