The following data is part of a premarket notification filed by Promisemed Hangzhou Meditech Co., Ltd. with the FDA for Common Type Insulin Pen Needle, Safety Type Insulin Pen Needle.
| Device ID | K161950 |
| 510k Number | K161950 |
| Device Name: | Common Type Insulin Pen Needle, Safety Type Insulin Pen Needle |
| Classification | Needle, Hypodermic, Single Lumen |
| Applicant | Promisemed Hangzhou Meditech Co., Ltd. No. 18 Haishu Road Future Sci-Tech Park, Yuhang District Hangzhou, CN Zj571 |
| Contact | Keshin Hu |
| Correspondent | Field Fu Shenzhen Joyantech Consulting Co., Ltd NO. 55 Shizhou Middle Road , Nanshan District Shenzhen, CN Gd755 |
| Product Code | FMI |
| CFR Regulation Number | 880.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-07-15 |
| Decision Date | 2017-05-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00015482280307 | K161950 | 000 |
| 00015482270308 | K161950 | 000 |
| 50015482234237 | K161950 | 000 |