VARIOGUIDE DRILL KIT

Drills, Burrs, Trephines & Accessories (simple, Powered)

MRI INTERVENTIONS, INC.

The following data is part of a premarket notification filed by Mri Interventions, Inc. with the FDA for Varioguide Drill Kit.

Pre-market Notification Details

Device IDK132436
510k NumberK132436
Device Name:VARIOGUIDE DRILL KIT
ClassificationDrills, Burrs, Trephines & Accessories (simple, Powered)
Applicant MRI INTERVENTIONS, INC. 5 MUSICK Irvine,  CA  92618
ContactE. F Waddell
CorrespondentE. F Waddell
MRI INTERVENTIONS, INC. 5 MUSICK Irvine,  CA  92618
Product CodeHBE  
CFR Regulation Number882.4310 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-08-05
Decision Date2014-03-20
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04056481006402 K132436 000

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