NovaLine Tubing Sets For Hemodialysis

Set, Tubing, Blood, With And Without Anti-regurgitation Valve

Bain Medical Equipment(Guangzhou) Co., Ltd.

The following data is part of a premarket notification filed by Bain Medical Equipment(guangzhou) Co., Ltd. with the FDA for Novaline Tubing Sets For Hemodialysis.

Pre-market Notification Details

Device IDK201866
510k NumberK201866
Device Name:NovaLine Tubing Sets For Hemodialysis
ClassificationSet, Tubing, Blood, With And Without Anti-regurgitation Valve
Applicant Bain Medical Equipment(Guangzhou) Co., Ltd. No.10, Juncheng Road, Eastern Area, Economic And Technological Development Guangzhou,  CN 510760
ContactZoe Zeng
CorrespondentZoe Zeng
Bain Medical Equipment(Guangzhou) Co., Ltd. No.10, Juncheng Road, Eastern Area, Economic And Technological Development Guangzhou,  CN 510760
Product CodeFJK  
CFR Regulation Number876.5820 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-07-07
Decision Date2021-03-10

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