The following data is part of a premarket notification filed by Berpu Medical Technology Co., Ltd with the FDA for Safety Insulin Needle For Single Use.
| Device ID | K181447 |
| 510k Number | K181447 |
| Device Name: | Safety Insulin Needle For Single Use |
| Classification | Needle, Hypodermic, Single Lumen |
| Applicant | Berpu Medical Technology Co., Ltd No. 14 Xingji Road, Yongxiing Street, Longwan District Wenzhou, CN 325000 |
| Contact | Jundong Tan |
| 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 | 2018-06-01 |
| Decision Date | 2019-03-12 |
| Summary: | summary |