The following data is part of a premarket notification filed by Well Lead Medical Co. Ltd with the FDA for Well Lead Silicone Catheter With Temperature Sensor.
| Device ID | K091516 |
| 510k Number | K091516 |
| Device Name: | WELL LEAD SILICONE CATHETER WITH TEMPERATURE SENSOR |
| Classification | Catheter, Retention Type, Balloon |
| Applicant | WELL LEAD MEDICAL CO. LTD 962 ALLEGRO LANE Apollo Beach, FL 33572 |
| Contact | Arthur Ward |
| Correspondent | Arthur Ward WELL LEAD MEDICAL CO. LTD 962 ALLEGRO LANE Apollo Beach, FL 33572 |
| Product Code | EZL |
| CFR Regulation Number | 876.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-05-22 |
| Decision Date | 2009-10-16 |
| Summary: | summary |