The following data is part of a premarket notification filed by Well Lead Medical Co., Ltd. with the FDA for Wei Nasal Jet Tube.
| Device ID | K211543 |
| 510k Number | K211543 |
| Device Name: | Wei Nasal Jet Tube |
| Classification | Tube, Tracheal (w/wo Connector) |
| Applicant | Well Lead Medical Co., LTD. C-4 Jinhu Industrial Estate Hualong, Panyu Guangzhou, CN 511434 |
| Contact | Caroline Gong |
| Correspondent | Diana Hong Mid-Link Consulting Co., Ltd P.O.BOX 120-119 Shanghai, CN 200120 |
| Product Code | BTR |
| CFR Regulation Number | 868.5730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-05-19 |
| Decision Date | 2022-07-21 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 16944932776262 | K211543 | 000 |
| 16944932776248 | K211543 | 000 |
| 16944932776224 | K211543 | 000 |