XPS 3000 SYSTEM

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 3000 System.

Pre-market Notification Details

Device IDK041523
510k NumberK041523
Device Name:XPS 3000 SYSTEM
ClassificationDrill, Surgical, Ent (electric Or Pneumatic) Including Handpiece
Applicant MEDTRONIC XOMED, INC. 6743 SOUTHPOINT DR. NORTH Jacksonville,  FL  32216
ContactMartin D Sargent
CorrespondentMartin D Sargent
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 Received2004-06-08
Decision Date2004-07-23
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00643169882713 K041523 000
00885074107349 K041523 000
00885074107332 K041523 000

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.