STRATA BURR HOLE VALVE, MODEL 42836 AND STRATA BURR HOLE SHUNT ASSEMBLY, MODEL 46836

Shunt, Central Nervous System And Components

MEDTRONIC NEUROSURGERY

The following data is part of a premarket notification filed by Medtronic Neurosurgery with the FDA for Strata Burr Hole Valve, Model 42836 And Strata Burr Hole Shunt Assembly, Model 46836.

Pre-market Notification Details

Device IDK083076
510k NumberK083076
Device Name:STRATA BURR HOLE VALVE, MODEL 42836 AND STRATA BURR HOLE SHUNT ASSEMBLY, MODEL 46836
ClassificationShunt, Central Nervous System And Components
Applicant MEDTRONIC NEUROSURGERY 125 CREMONA DR. Goleta,  CA  93117
ContactJeffrey Henderson
CorrespondentJeffrey Henderson
MEDTRONIC NEUROSURGERY 125 CREMONA DR. Goleta,  CA  93117
Product CodeJXG  
CFR Regulation Number882.5550 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2008-10-16
Decision Date2008-11-20
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00613994380111 K083076 000
00613994380098 K083076 000
00643169975941 K083076 000
00643169975811 K083076 000
00643169840980 K083076 000
00643169840959 K083076 000
00763000031237 K083076 000
00763000031398 K083076 000

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