The following data is part of a premarket notification filed by W.o.m. World Of Medicine Ag with the FDA for Uro Pro.
| Device ID | K042457 |
| 510k Number | K042457 |
| Device Name: | URO PRO |
| Classification | System, Irrigation, Urological |
| Applicant | W.O.M. WORLD OF MEDICINE AG 119 SOUTH ST. Hingham, MA 02043 |
| Contact | Susanne Raab |
| Correspondent | Susanne Raab W.O.M. WORLD OF MEDICINE AG 119 SOUTH ST. Hingham, MA 02043 |
| Product Code | LJH |
| CFR Regulation Number | 876.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-09-10 |
| Decision Date | 2004-10-25 |
| Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() URO PRO 78241620 2960953 Dead/Cancelled |
W.O.M. WORLD OF MEDICINE USA, Inc. 2003-04-24 |