XPS 3000 SYSTEM

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

MEDTRONIC XOMED

The following data is part of a premarket notification filed by Medtronic Xomed with the FDA for Xps 3000 System.

Pre-market Notification Details

Device IDK002224
510k NumberK002224
Device Name:XPS 3000 SYSTEM
ClassificationDrill, Surgical, Ent (electric Or Pneumatic) Including Handpiece
Applicant MEDTRONIC XOMED 6743 SOUTHPOINT DR. NORTH Jacksonville,  FL  32216
ContactMartin D Sargent
CorrespondentMartin D Sargent
MEDTRONIC XOMED 6743 SOUTHPOINT DR. NORTH Jacksonville,  FL  32216
Product CodeERL  
CFR Regulation Number874.4250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2000-07-24
Decision Date2000-12-04

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
20613994921752 K002224 000
00643169360846 K002224 000
00643169350663 K002224 000
20681490049133 K002224 000
00721902773013 K002224 000

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