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 |