The following data is part of a premarket notification filed by Promisemed Hangzhou Meditech Co., Ltd. with the FDA for Dual-safety Pen Needle.
| Device ID | K191853 |
| 510k Number | K191853 |
| Device Name: | Dual-Safety Pen Needle |
| Classification | Needle, Hypodermic, Single Lumen |
| Applicant | Promisemed Hangzhou Meditech Co., Ltd. Bldg. 1, No. 12, Longtan Road, Cangqian Street Yuhang District Hangzhou City, CN |
| Contact | Zearou Yang |
| Correspondent | John Beasley MedTech Review, LLC 257 Garnet Garden Street Henderson, NV 98015 |
| Product Code | FMI |
| CFR Regulation Number | 880.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-07-10 |
| Decision Date | 2019-09-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00015482273835 | K191853 | 000 |
| 00015482273538 | K191853 | 000 |
| 10015482272835 | K191853 | 000 |
| 10015482272538 | K191853 | 000 |