The following data is part of a premarket notification filed by Beijing Zksk Technology Co.,ltd with the FDA for Endoscopic Injection Needle.
|Device Name:||Endoscopic Injection Needle|
|Classification||Endoscopic 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|
Shanghai Truthful Information Technology Co., Ltd. RM.1801,No.161,East Lujiazui Rd.,Pudong Shanghai, CN 200120
|CFR Regulation Number||876.1500 [🔎]|
|Decision||Substantially Equivalent (SESE)|
|3rd Party Reviewed||No|