The following data is part of a premarket notification filed by Henan Tuoren Medical Device Co., Ltd with the FDA for Endobronchial Tube.
| Device ID | K152251 |
| 510k Number | K152251 |
| Device Name: | Endobronchial Tube |
| Classification | Tube, Tracheal/bronchial, Differential Ventilation (w/wo Connector) |
| Applicant | HENAN TUOREN MEDICAL DEVICE CO., LTD WEIYUAN INDUSTRIAL ZONE, MENGGANG, CHANGYUAN COUNTRY Xinxiang, CN 453400 |
| Contact | Meizi Zhang |
| Correspondent | Long Yang SHENZHEN HLONGMED BIOTECH COMPANY R150-08, EAST BUILDING, YIHAI PLAZA, CHUANGYE ROAD, NANSHAN DISTRICT Shenzhen, CN 518054 |
| Product Code | CBI |
| CFR Regulation Number | 868.5740 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-08-10 |
| Decision Date | 2016-06-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 16938119326623 | K152251 | 000 |
| 16938119325176 | K152251 | 000 |
| 06938119326473 | K152251 | 000 |
| 16938119326487 | K152251 | 000 |
| 06938119326497 | K152251 | 000 |
| 16938119326500 | K152251 | 000 |
| 16938119326517 | K152251 | 000 |
| 16938119326524 | K152251 | 000 |
| 16938119326531 | K152251 | 000 |
| 16938119326548 | K152251 | 000 |
| 16938119326555 | K152251 | 000 |
| 16938119326562 | K152251 | 000 |
| 16938119326579 | K152251 | 000 |
| 16938119326586 | K152251 | 000 |
| 16938119326593 | K152251 | 000 |
| 16938119326609 | K152251 | 000 |
| 16938119326616 | K152251 | 000 |
| 16938119303556 | K152251 | 000 |