Endoscopic Injection Needle

Endoscopic Injection Needle, Gastroenterology-urology

Beijing ZKSK Technology Co.,Ltd

The following data is part of a premarket notification filed by Beijing Zksk Technology Co.,ltd with the FDA for Endoscopic Injection Needle.

Pre-market Notification Details

Device IDK213239
510k NumberK213239
Device Name:Endoscopic Injection Needle
ClassificationEndoscopic Injection Needle, Gastroenterology-urology
Applicant Beijing ZKSK Technology Co.,Ltd Building 9, 6 & No.6 Yuan Hengye North 7th Street, Yongle Economic Development Zone, Tongzho Beijing,  CN 101105
ContactMa Li
CorrespondentBoyle Wang
Shanghai Truthful Information Technology Co., Ltd. RM.1801,No.161,East Lujiazui Rd.,Pudong Shanghai,  CN 200120
Product CodeFBK  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-09-30
Decision Date2022-06-02

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