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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 K091312
Device Name PS MEDICAL STRATA NSC LUMBOPERITONEAL VALVE AND SHUNT SYSTEM
Applicant
MEDTRONIC NEUROSURGERY
125 CREMONA DR.
GOLETA,  CA  93117
Applicant Contact JEFFERY HENDERSON
Correspondent
MEDTRONIC NEUROSURGERY
125 CREMONA DR.
GOLETA,  CA  93117
Correspondent Contact JEFFERY HENDERSON
Regulation Number882.5550
Classification Product Code
JXG  
Date Received05/04/2009
Decision Date 09/02/2009
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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