The following data is part of a premarket notification filed by Zhanjiang Star Enterprise Co., Ltd with the FDA for Endotracheal Tube; Reinforced Endotracheal Tube.
| Device ID | K170234 |
| 510k Number | K170234 |
| Device Name: | Endotracheal Tube; Reinforced Endotracheal Tube |
| Classification | Tube, Tracheal (w/wo Connector) |
| Applicant | Zhanjiang Star Enterprise Co., Ltd NO.1, West Jinhua Rd. Zhanjiang, TW 524094 |
| Contact | Rongsheng Tang |
| Correspondent | Jessie You Shenzhen Joyantech Consulting Co., Ltd Room 1122, No.55 Shizhou Middle Road Nanshan District Shenzhen, TW Gd755 |
| Product Code | BTR |
| CFR Regulation Number | 868.5730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-01-25 |
| Decision Date | 2018-01-17 |
| Summary: | summary |