Device Classification Name |
system, irrigation, urological
|
510(k) Number |
K042457 |
Device Name |
URO PRO |
Applicant |
W.O.M. WORLD OF MEDICINE AG |
119 SOUTH ST. |
HINGHAM,
MA
02043
|
|
Applicant Contact |
SUSANNE RAAB |
Correspondent |
W.O.M. WORLD OF MEDICINE AG |
119 SOUTH ST. |
HINGHAM,
MA
02043
|
|
Correspondent Contact |
SUSANNE RAAB |
Regulation Number | 876.5130
|
Classification Product Code |
|
Date Received | 09/10/2004 |
Decision Date | 10/25/2004 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|