The following data is part of a premarket notification filed by Well Lead Medical Co., Ltd. with the FDA for Well Lead Pvc Urethral Catheter.
| Device ID | K142563 |
| 510k Number | K142563 |
| Device Name: | Well Lead PVC Urethral Catheter |
| Classification | Catheter, Straight |
| Applicant | WELL LEAD MEDICAL CO., LTD. C-4#Jinhu Industrial Estate, Hualong, Panyu Guangzhou, CN 511434 |
| Contact | Han Guang Yuan |
| Correspondent | Han Guang Yuan WELL LEAD MEDICAL CO., LTD. C-4#Jinhu Industrial Estate, Hualong, Panyu Guangzhou, CN 511434 |
| Product Code | EZD |
| CFR Regulation Number | 876.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-09-11 |
| Decision Date | 2014-10-28 |
| Summary: | summary |