FDA.report

510(k) K073255

Device
XPS 3000 SYSTEM
Applicant
MEDTRONIC XOMED, INC.
510(k) number
K073255
Product code
ERL  
Decision
Substantially Equivalent (SESE)
Decision date
2008-03-24
Date received
2007-11-19
Regulation
874.4250
Classification name
Drill, Surgical, Ent (electric Or Pneumatic) Including Handpiece
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
DAVID GUZEK
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

Legacy Summary

summary

FDA Review

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