The following data is part of a premarket notification filed by Berpu Medical Technology Co., Ltd. with the FDA for Safety Pen Needle For Single Use, Insulin Pen Needles.
| Device ID | K212514 |
| 510k Number | K212514 |
| Device Name: | Safety Pen Needle For Single Use, Insulin Pen Needles |
| Classification | Needle, Hypodermic, Single Lumen |
| Applicant | Berpu Medical Technology Co., Ltd. NO.14 Xingji Road,Yongxing Street, Longwan District Wenzhou, CN 325000 |
| Contact | Buxin Yu |
| Correspondent | Diana Hong Mid-Link Consulting Co., Ltd P.O. Box 120-119 Shanghai, CN 200120 |
| Product Code | FMI |
| CFR Regulation Number | 880.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-08-10 |
| Decision Date | 2022-04-29 |