MODIFICATION TO 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 Modification To Xps 3000 System.

Pre-market Notification Details

Device IDK011321
510k NumberK011321
Device Name:MODIFICATION TO 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 Received2001-04-27
Decision Date2001-06-26

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00643169882843 K011321 000
00643169882690 K011321 000
00643169564749 K011321 000
00643169360945 K011321 000
00643169360938 K011321 000

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