FDA.report

510(k) K922880

Device
XOMED TREACE JET VENTILATION TUBE
Applicant
XOMED-TREACE, INC.
510(k) number
K922880
Product code
BTR  
Decision
Substantially Equivalent (SESE)
Decision date
1993-04-15
Date received
1992-06-15
Regulation
868.5730
Classification name
Tube, Tracheal (w/wo Connector)
Medical specialty
Anesthesiology
Review panel
Anesthesiology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
TERRY C MCMAHON
Address
6743 Southpoint Dr. N. Jacksonville FL US 32216 32216

FDA Registration Numbers

Source Documents

FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON

Related GUDID Devices

Primary DIBrandCompanyPublished
00681490156431HunsakerMEDTRONIC XOMED, INC.2015-07-06

Legacy Summary

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FDA Review

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