WELL LEAD REINFORCED ENDOTRACHEAL TUBE

Tube, Tracheal (w/wo Connector)

WELL LEAD MEDICAL INSTRUMENTS

The following data is part of a premarket notification filed by Well Lead Medical Instruments with the FDA for Well Lead Reinforced Endotracheal Tube.

Pre-market Notification Details

Device IDK073383
510k NumberK073383
Device Name:WELL LEAD REINFORCED ENDOTRACHEAL TUBE
ClassificationTube, Tracheal (w/wo Connector)
Applicant WELL LEAD MEDICAL INSTRUMENTS 962 ALLERGO LANE Apollo Beach,  FL  33572
ContactArthur J Ward
CorrespondentArthur J Ward
WELL LEAD MEDICAL INSTRUMENTS 962 ALLERGO LANE Apollo Beach,  FL  33572
Product CodeBTR  
CFR Regulation Number868.5730 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2007-12-03
Decision Date2008-07-10
Summary:summary

NIH GUDID Devices

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