The following data is part of a premarket notification filed by Leomed, Llc with the FDA for Wijay Ez-void External Catheter Valve.
| Device ID | K140562 |
| 510k Number | K140562 |
| Device Name: | WIJAY EZ-VOID EXTERNAL CATHETER VALVE |
| Classification | Accessories, Catheter, G-u |
| Applicant | LEOMED, LLC 9001 AIRPORT BLVD SUITE 503 Houston, TX 77061 |
| Contact | Bandula Wijay |
| Correspondent | Bandula Wijay LEOMED, LLC 9001 AIRPORT BLVD SUITE 503 Houston, TX 77061 |
| Product Code | KNY |
| CFR Regulation Number | 876.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-03-05 |
| Decision Date | 2014-06-16 |