EUROMEDICAL REINFORCED ENDOTRACHEAL TUBE

Tube, Tracheal (w/wo Connector)

UNOMEDICAL SDN BHD

The following data is part of a premarket notification filed by Unomedical Sdn Bhd with the FDA for Euromedical Reinforced Endotracheal Tube.

Pre-market Notification Details

Device IDK962389
510k NumberK962389
Device Name:EUROMEDICAL REINFORCED ENDOTRACHEAL TUBE
ClassificationTube, Tracheal (w/wo Connector)
Applicant UNOMEDICAL SDN BHD 40178 U.S. 19 NORTH Tarpon Springs,  FL  34689
ContactPatrick J Lamb
CorrespondentPatrick J Lamb
UNOMEDICAL SDN BHD 40178 U.S. 19 NORTH Tarpon Springs,  FL  34689
Product CodeBTR  
CFR Regulation Number868.5730 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1996-06-20
Decision Date1996-11-21

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