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 |