The following data is part of a premarket notification filed by Tianjin Huahong Technology Co., Ltd. with the FDA for Insulin Pen Needle.
| Device ID | K221176 |
| 510k Number | K221176 |
| Device Name: | Insulin Pen Needle |
| Classification | Needle, Hypodermic, Single Lumen |
| Applicant | Tianjin Huahong Technology Co., Ltd. A01, Plant B, No. 278, Hangkong Road, Tianjin Pilot Free Trade Zone(Air Port Industrial Park) Tianjin, CN 300308 |
| Contact | Yuan Ying |
| Correspondent | Yuan Ying Tianjin Huahong Technology Co., Ltd. A01, Plant B, No. 278, Hangkong Road, Tianjin Pilot Free Trade Zone(Air Port Industrial Park) Tianjin, CN 300308 |
| Product Code | FMI |
| CFR Regulation Number | 880.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-04-25 |
| Decision Date | 2022-07-01 |