Single Use Injection Needle

Endoscopic Injection Needle, Gastroenterology-urology

Anrei Medical (Hangzhou) Co., Ltd.

The following data is part of a premarket notification filed by Anrei Medical (hangzhou) Co., Ltd. with the FDA for Single Use Injection Needle.

Pre-market Notification Details

Device IDK210917
510k NumberK210917
Device Name:Single Use Injection Needle
ClassificationEndoscopic Injection Needle, Gastroenterology-urology
Applicant Anrei Medical (Hangzhou) Co., Ltd. No.3 Ave.8, HEDA Hangzhou,  CN 310018
ContactHuibing Yang
CorrespondentHuibing Yang
Anrei Medical (Hangzhou) Co., Ltd. No.3 Ave.8, HEDA Hangzhou,  CN 310018
Product CodeFBK  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-03-29
Decision Date2021-05-28

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