The following data is part of a premarket notification filed by Tianjin Huahong Technology Co., Ltd. with the FDA for Insulin Pen Needle (ordinary Type), Insulin Pen Needle (safety Type).
Device ID | K202319 |
510k Number | K202319 |
Device Name: | Insulin Pen Needle (Ordinary Type), Insulin Pen Needle (Safety Type) |
Classification | Needle, Hypodermic, Single Lumen |
Applicant | Tianjin Huahong Technology Co., Ltd. A01, Plant B, No. 278, Hangkong Road, Tianjin Pilot Free Trade Zone Tianjin, CN 300308 |
Contact | Yan Li |
Correspondent | Yan Li Tianjin Huahong Technology Co., Ltd. A01, Plant B, No. 278, Hangkong Road, Tianjin Pilot Free Trade Zone Tianjin, CN 300308 |
Product Code | FMI |
CFR Regulation Number | 880.5570 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2020-08-17 |
Decision Date | 2021-11-12 |