The following data is part of a premarket notification filed by Berpu Medical Technology Co., Ltd with the FDA for Insulin Syringes Without Needle.
|Device Name:||Insulin Syringes Without Needle|
|Applicant||Berpu Medical Technology Co., Ltd No. 14 Xingji Road, Yongxing Street, Longwan District Wenzhou, CN 325000|
Berpu Medical Technology Co., Ltd No. 14 Xingji Road, Yongxing Street, Longwan District Wenzhou, CN 325000
|CFR Regulation Number||880.5860 [🔎]|
|Decision||Substantially Equivalent (SESE)|
|3rd Party Reviewed||No|