The following data is part of a premarket notification filed by Zhejiang Kindley Medical Devices Co.,ltd with the FDA for Disposable Insulin Pen Needle.
| Device ID | K181069 |
| 510k Number | K181069 |
| Device Name: | Disposable Insulin Pen Needle |
| Classification | Needle, Hypodermic, Single Lumen |
| Applicant | Zhejiang Kindley Medical Devices Co.,Ltd No.758, 5th Binhai Road, Binhai Industrial Park Longwan District Wenzhou, CN 325000 |
| Contact | Yong Zhang |
| 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 | 2018-04-23 |
| Decision Date | 2018-08-28 |
| Summary: | summary |