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 ID | K221045 |
| 510k Number | K221045 |
| Device Name: | Insulin Syringes Without Needle |
| Classification | Syringe, Piston |
| Applicant | Berpu Medical Technology Co., Ltd No. 14 Xingji Road, Yongxing Street, Longwan District Wenzhou, CN 325000 |
| Contact | Buxin Yu |
| Correspondent | Buxin Yu Berpu Medical Technology Co., Ltd No. 14 Xingji Road, Yongxing Street, Longwan District 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 | 2022-04-08 |
| Decision Date | 2022-11-03 |