FDA.report

510(k) K041985

Device
XPS CURVED BUR
Applicant
MEDTRONIC XOMED, INC.
510(k) number
K041985
Product code
EQJ  
Decision
Substantially Equivalent (SESE)
Decision date
2004-08-12
Date received
2004-07-23
Regulation
874.4140
Classification name
Bur, Ear, Nose And Throat
Medical specialty
Ear Nose & Throat
Review panel
Ear Nose & Throat
Device class
1
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
Yes
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
MARTIN D SARGENT
Address
6743 Southpoint Dr. N. Jacksonville FL US 32216 32216

FDA Registration Numbers

Source Documents

FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON

Related GUDID Devices

Primary DIBrandCompanyPublished
00613994223470Visao®MEDTRONIC XOMED, INC.2016-04-29
00613994223463Visao®MEDTRONIC XOMED, INC.2016-04-29
00613994223449Visao®MEDTRONIC XOMED, INC.2016-04-29
00613994223425Visao®MEDTRONIC XOMED, INC.2016-04-29
00613994223418Visao®MEDTRONIC XOMED, INC.2016-04-29

Legacy Summary

summary

FDA Review

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