The following data is part of a premarket notification filed by Promisemed Hangzhou Meditech Co., Ltd. with the FDA for Safety Winged Blood Collection Sets.
| Device ID | K211293 |
| 510k Number | K211293 |
| Device Name: | Safety Winged Blood Collection Sets |
| Classification | Needle, Hypodermic, Single Lumen |
| Applicant | Promisemed Hangzhou Meditech Co., Ltd. No. 12 Longtan Road, Cangqian Street Yuhang District Hangzhou City, CN 311121 |
| Contact | Zearou Yang |
| Correspondent | John Beasley MedTech Review, LLC 257 Garnet Garden Street Henderson, NV 89015 |
| Product Code | FMI |
| CFR Regulation Number | 880.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-04-26 |
| Decision Date | 2021-06-25 |