The following data is part of a premarket notification filed by Well Lead Medical Co., Ltd. with the FDA for Endotracheal Tube With Evacuation Lumen.
| Device ID | K182739 |
| 510k Number | K182739 |
| Device Name: | Endotracheal Tube With Evacuation Lumen |
| Classification | Tube, Tracheal (w/wo Connector) |
| Applicant | WELL LEAD MEDICAL CO., LTD. C-4 # Jinhu Industrial Estate, Hualong, Panyu Guangzhou, CN 511434 |
| Contact | Huang Kaigen |
| Correspondent | Jenny Zhu WELL LEAD MEDICAL CO., LTD. No.47, Guomao Avenue South, Hualong, Panyu Guangzhou, CN 511434 |
| Product Code | BTR |
| CFR Regulation Number | 868.5730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-09-28 |
| Decision Date | 2019-12-11 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 24026704664652 | K182739 | 000 |
| 16944932784045 | K182739 | 000 |
| 16944932784021 | K182739 | 000 |
| 16944932774923 | K182739 | 000 |
| 16944932774909 | K182739 | 000 |
| 16944932774886 | K182739 | 000 |
| 16944932774862 | K182739 | 000 |
| 16944932774848 | K182739 | 000 |
| 16944932774824 | K182739 | 000 |
| 16944932784069 | K182739 | 000 |
| 16944932784083 | K182739 | 000 |
| 16944932784106 | K182739 | 000 |
| 34026704664642 | K182739 | 000 |
| 34026704664635 | K182739 | 000 |
| 34026704664628 | K182739 | 000 |
| 24026704664614 | K182739 | 000 |
| 24026704664607 | K182739 | 000 |
| 24026704664591 | K182739 | 000 |
| 16944932784144 | K182739 | 000 |
| 16944932784120 | K182739 | 000 |
| 16944932774800 | K182739 | 000 |