The following data is part of a premarket notification filed by Well Lead Medical Co., Ltd with the FDA for Stomach Tube.
| Device ID | K162340 |
| 510k Number | K162340 |
| Device Name: | Stomach Tube |
| Classification | Tubes, Gastrointestinal (and Accessories) |
| Applicant | WELL LEAD MEDICAL CO., LTD C-4# JINHU INDUSTRIAL ESTATE HUALONG, PANYU Guangzhou, CN 511434 |
| Contact | Huang Kai Gen |
| Correspondent | Huang Kai Gen WELL LEAD MEDICAL CO., LTD C-4# JINHU INDUSTRIAL ESTATE HUALONG, PANYU Guangzhou, CN 511434 |
| Product Code | KNT |
| CFR Regulation Number | 876.5980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-08-22 |
| Decision Date | 2017-10-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 16944932758565 | K162340 | 000 |
| 16936881127011 | K162340 | 000 |
| 16936881127028 | K162340 | 000 |
| 16936881127035 | K162340 | 000 |
| 16936881127042 | K162340 | 000 |
| 16936881127059 | K162340 | 000 |
| 16936881127066 | K162340 | 000 |
| 16936881135764 | K162340 | 000 |
| 16936881148771 | K162340 | 000 |
| 16944932758480 | K162340 | 000 |
| 16944932758497 | K162340 | 000 |
| 16944932758503 | K162340 | 000 |
| 16944932758510 | K162340 | 000 |
| 16944932758527 | K162340 | 000 |
| 16944932758534 | K162340 | 000 |
| 16944932758541 | K162340 | 000 |
| 16944932758558 | K162340 | 000 |
| 16936881127004 | K162340 | 000 |