XPS 4000 SYSTEM, MIDAS REX LEGEND EHS SYSTEM, INTEGRATED POWER CONS0LE (IPC)

Drill, Surgical, Ent (electric Or Pneumatic) Including Handpiece

MEDTRONIC XOMED, INC.

The following data is part of a premarket notification filed by Medtronic Xomed, Inc. with the FDA for Xps 4000 System, Midas Rex Legend Ehs System, Integrated Power Cons0le (ipc).

Pre-market Notification Details

Device IDK081277
510k NumberK081277
Device Name:XPS 4000 SYSTEM, MIDAS REX LEGEND EHS SYSTEM, INTEGRATED POWER CONS0LE (IPC)
ClassificationDrill, Surgical, Ent (electric Or Pneumatic) Including Handpiece
Applicant MEDTRONIC XOMED, INC. 6743 SOUTHPOINT DR. NORTH Jacksonville,  FL  32216
ContactAntoine Kouchakjy
CorrespondentAntoine Kouchakjy
MEDTRONIC XOMED, INC. 6743 SOUTHPOINT DR. NORTH Jacksonville,  FL  32216
Product CodeERL  
CFR Regulation Number874.4250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2008-05-05
Decision Date2008-09-05
Summary:summary

NIH GUDID Devices

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