XPS STRAIGHTSHOT MICROBRIDER SYSTEM OR TREBAY SHAVER SYSTEM

Arthroscope

XOMED, INC.

The following data is part of a premarket notification filed by Xomed, Inc. with the FDA for Xps Straightshot Microbrider System Or Trebay Shaver System.

Pre-market Notification Details

Device IDK973499
510k NumberK973499
Device Name:XPS STRAIGHTSHOT MICROBRIDER SYSTEM OR TREBAY SHAVER SYSTEM
ClassificationArthroscope
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 CodeHRX  
CFR Regulation Number888.1100 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1997-09-16
Decision Date1998-01-30
Summary:summary

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