Huber Needle Infusion Set, Safety Huber Needle Infusion Set

Non-coring (huber) Needle

Jiangsu Caina Medical Co., Ltd.

The following data is part of a premarket notification filed by Jiangsu Caina Medical Co., Ltd. with the FDA for Huber Needle Infusion Set, Safety Huber Needle Infusion Set.

Pre-market Notification Details

Device IDK200463
510k NumberK200463
Device Name:Huber Needle Infusion Set, Safety Huber Needle Infusion Set
ClassificationNon-coring (huber) Needle
Applicant Jiangsu Caina Medical Co., Ltd. No.23, Huanxi Rd, Zhutang Town Jiangyin,  CN 214415
ContactJianwei Pan
CorrespondentDiana Hong
Mid-Link Consulting Co., Ltd. P.O.BOX 120-119 Shanghai,  CN 200120
Product CodePTI  
CFR Regulation Number880.5570 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-02-25
Decision Date2021-04-07

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