SILBRONCHO DOUBLE LUMEN TUBE

Tube, Tracheal/bronchial, Differential Ventilation (w/wo Connector)

FUJI SYSTEMS CORP.

The following data is part of a premarket notification filed by Fuji Systems Corp. with the FDA for Silbroncho Double Lumen Tube.

Pre-market Notification Details

Device IDK051522
510k NumberK051522
Device Name:SILBRONCHO DOUBLE LUMEN TUBE
ClassificationTube, Tracheal/bronchial, Differential Ventilation (w/wo Connector)
Applicant FUJI SYSTEMS CORP. 6329 W. WATERVIEW COURT Mccordsville,  IN  46055 -9501
ContactPaul E Dryden
CorrespondentPaul E Dryden
FUJI SYSTEMS CORP. 6329 W. WATERVIEW COURT Mccordsville,  IN  46055 -9501
Product CodeCBI  
CFR Regulation Number868.5740 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2005-06-08
Decision Date2005-08-17
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04544050083959 K051522 000
14544050123942 K051522 000
14544050123959 K051522 000
14544050123966 K051522 000
14544050123973 K051522 000
14544050123980 K051522 000
14544050123997 K051522 000
14544050124000 K051522 000
04544050061148 K051522 000
04544050061186 K051522 000
04544050061193 K051522 000
04544050061209 K051522 000
04544050083928 K051522 000
04544050083935 K051522 000
04544050083942 K051522 000
04544050123938 K051522 000

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