XPS STRAIGHTSHOT OR MODEL 2000 MICRODEBRIDER SYSTEM OR XPS POWERSCULPT

System, Suction, Lipoplasty

XOMED, INC.

The following data is part of a premarket notification filed by Xomed, Inc. with the FDA for Xps Straightshot Or Model 2000 Microdebrider System Or Xps Powersculpt.

Pre-market Notification Details

Device IDK992855
510k NumberK992855
Device Name:XPS STRAIGHTSHOT OR MODEL 2000 MICRODEBRIDER SYSTEM OR XPS POWERSCULPT
ClassificationSystem, Suction, Lipoplasty
Applicant XOMED, INC. 6743 SOUTHPOINT DR. NORTH Jacksonville,  FL  32216 -0980
ContactDavid Timlin
CorrespondentDavid Timlin
XOMED, INC. 6743 SOUTHPOINT DR. NORTH Jacksonville,  FL  32216 -0980
Product CodeMUU  
CFR Regulation Number878.5040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1999-08-24
Decision Date2000-01-21
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00681490693950 K992855 000

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