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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 K063836
Device Name RIVULET VENTRICULAR AND SNAP SHUNT AND CONVERTIBLE VENTRICULAR CATHETERS, MODELS 41701 AND 41704-41715
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 Received12/26/2006
Decision Date 08/16/2007
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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