FDA.report

510(k) K063305

Device
STIMULATING BUR GUARD
Applicant
MEDTRONIC XOMED, INC.
510(k) number
K063305
Product code
ETN  
Decision
Substantially Equivalent (SESE)
Decision date
2006-11-29
Date received
2006-11-01
Regulation
874.1820
Classification name
Stimulator, Nerve
Medical specialty
Ear Nose & Throat
Review panel
Ear Nose & Throat
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
ANTOINE KOUCHAKJY
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
00763000576776N/AMEDTRONIC XOMED, INC.2024-09-14
00763000576769N/AMEDTRONIC XOMED, INC.2024-09-14
00613994315977NAMEDTRONIC XOMED, INC.2016-04-29
00613994315960NAMEDTRONIC XOMED, INC.2016-04-29

Legacy Summary

summary

FDA Review

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