Wei Nasal Jet Tube

Tube, Tracheal (w/wo Connector)

Well Lead Medical Co., LTD.

The following data is part of a premarket notification filed by Well Lead Medical Co., Ltd. with the FDA for Wei Nasal Jet Tube.

Pre-market Notification Details

Device IDK211543
510k NumberK211543
Device Name:Wei Nasal Jet Tube
ClassificationTube, Tracheal (w/wo Connector)
Applicant Well Lead Medical Co., LTD. C-4 Jinhu Industrial Estate Hualong, Panyu Guangzhou,  CN 511434
ContactCaroline Gong
CorrespondentDiana Hong
Mid-Link Consulting Co., Ltd P.O.BOX 120-119 Shanghai,  CN 200120
Product CodeBTR  
CFR Regulation Number868.5730 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-05-19
Decision Date2022-07-21

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