The following data is part of a premarket notification filed by Zhejiang Kindly Medical Devices Co. Ltd with the FDA for Safety Insulin Pen Needles.
| Device ID | K213183 |
| 510k Number | K213183 |
| Device Name: | Safety Insulin Pen Needles |
| Classification | Needle, Hypodermic, Single Lumen |
| Applicant | Zhejiang Kindly Medical Devices Co. Ltd No.758, 5th Binhai Road, Binhai Industrial Park Longwan District Wenzhou, CN 325025 |
| Contact | Yong Zhang |
| Correspondent | Alice Huang Shanghai Mind-link Business Consulting Co., Ltd. Room 8208, Second Floor, No 1399, Jiangyue Road, Minhang District Shanghai, CN 201114 |
| Product Code | FMI |
| CFR Regulation Number | 880.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-09-29 |
| Decision Date | 2022-10-14 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00810143550504 | K213183 | 000 |
| 00810143550481 | K213183 | 000 |
| 10810143550402 | K213183 | 000 |