The following data is part of a premarket notification filed by Berpu Medical Technology Co., Ltd. with the FDA for Syringe With Permanently Attached Needle, Safety Syringe With Permanently Attached Needle.
Device ID | K213158 |
510k Number | K213158 |
Device Name: | Syringe With Permanently Attached Needle, Safety Syringe With Permanently Attached Needle |
Classification | Syringe, Piston |
Applicant | Berpu Medical Technology Co., Ltd. No. 14 Xingji Road, Yongxing Street, Wenzhou, CN 325000 |
Contact | David Yu |
Correspondent | David Yu Berpu Medical Technology Co., Ltd. No. 14 Xingji Road, Yongxing Street, Wenzhou, CN 325000 |
Product Code | FMF |
CFR Regulation Number | 880.5860 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2021-09-28 |
Decision Date | 2022-07-21 |