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U.S. Department of Health and Human Services

510(k) Premarket Notification
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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 Number876.5130
Classification Product Code
LJH  
Date Received09/10/2004
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
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