STRATA NSC BURR HOLE VALVE, MODEL 42335; SHUNT ASSEMBLY, MODEL 46635

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 Nsc Burr Hole Valve, Model 42335; Shunt Assembly, Model 46635.

Pre-market Notification Details

Device IDK082127
510k NumberK082127
Device Name:STRATA NSC BURR HOLE VALVE, MODEL 42335; SHUNT ASSEMBLY, MODEL 46635
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 Received2008-07-29
Decision Date2008-08-27
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00613994380128 K082127 000
00613994380104 K082127 000
00643169975910 K082127 000
00643169975781 K082127 000
00643169840973 K082127 000
00643169840942 K082127 000
00763000031220 K082127 000
00763000031381 K082127 000

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