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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 K083076
Device Name STRATA BURR HOLE VALVE, MODEL 42836 AND STRATA BURR HOLE SHUNT ASSEMBLY, MODEL 46836
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 Received10/16/2008
Decision Date 11/20/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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