PEDIATRIC WIRE REINFORCED SILICONE 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 Pediatric Wire Reinforced Silicone Endotracheal Tube.

Pre-market Notification Details

Device IDK954750
510k NumberK954750
Device Name:PEDIATRIC WIRE REINFORCED SILICONE ENDOTRACHEAL TUBE
ClassificationTube, Tracheal (w/wo Connector)
Applicant UNOMEDICAL SDN BHD P.O. BOX NO. 18 SUNGEI PATANI KEDAH West Malaysia,  MY
ContactPatrick J Lamb
CorrespondentPatrick J Lamb
UNOMEDICAL SDN BHD P.O. BOX NO. 18 SUNGEI PATANI KEDAH West Malaysia,  MY
Product CodeBTR  
CFR Regulation Number868.5730 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-10-16
Decision Date1995-12-08

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