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 |