The following data is part of a premarket notification filed by Well Lead Medical Co. Ltd with the FDA for Well Lead Hydrophilic Silicone Foley Catheter.
| Device ID | K140667 |
| 510k Number | K140667 |
| Device Name: | WELL LEAD HYDROPHILIC SILICONE FOLEY CATHETER |
| Classification | Catheter, Retention Type, Balloon |
| Applicant | WELL LEAD MEDICAL CO. LTD C-4 JINHU INDUSTRIAL ESTATE HUALONG, PAN YU Guangzhou, CN 511434 |
| Contact | Han Guang Yuan |
| Correspondent | Han Guang Yuan WELL LEAD MEDICAL CO. LTD C-4 JINHU INDUSTRIAL ESTATE HUALONG, PAN YU Guangzhou, CN 511434 |
| Product Code | EZL |
| CFR Regulation Number | 876.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-03-18 |
| Decision Date | 2014-12-15 |
| Summary: | summary |