The following data is part of a premarket notification filed by Promisemed Hangzhou Meditech Co., Ltd. with the FDA for Promisemed Insulin Pen Needle.
| Device ID | K210059 |
| 510k Number | K210059 |
| Device Name: | Promisemed Insulin Pen Needle |
| Classification | Needle, Hypodermic, Single Lumen |
| Applicant | Promisemed Hangzhou Meditech Co., Ltd. No. 1388 Cangxing Street, Cangqian Community,Yuhang District Hangzhou City, CN 311121 |
| Contact | Zearou Yang |
| Correspondent | Wei Shan Hsu Vee Care (Asia) Limited 17th Chung Pont Commercial Building, 300 Hennessy Road Hong Kong, CN |
| Product Code | FMI |
| CFR Regulation Number | 880.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-01-11 |
| Decision Date | 2021-07-21 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 16975965297257 | K210059 | 000 |