The following data is part of a premarket notification filed by Ningbo Medsun Medical Co., Ltd. with the FDA for Disposable Insulin Pen Needle.
| Device ID | K221178 |
| 510k Number | K221178 |
| Device Name: | Disposable Insulin Pen Needle |
| Classification | Needle, Hypodermic, Single Lumen |
| Applicant | Ningbo Medsun Medical Co., Ltd. No.55 Jinxi Road, Zhenhai Ningbo, CN 315221 |
| Contact | Liu Ping |
| Correspondent | Marvin Li Shanghai Mihe Enterprise Management Consulting Co., Ltd. Room 313, No. 620 Zhennan Road (Building 9, Tongji University Science Park), Putuo District Shanghai, CN 200331 |
| Product Code | FMI |
| CFR Regulation Number | 880.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-04-25 |
| Decision Date | 2022-11-17 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 16934047902519 | K221178 | 000 |
| 16934047902502 | K221178 | 000 |