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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Uroflowmeter
510(k) Number K022721
Device Name UROPOWER
Applicant
W.O.M. WORLD OF MEDICINE AG
368 NORTH ASAPH STREET
ALEXANDRIA,  VA  22314
Applicant Contact SUSANNE RAAB
Correspondent
W.O.M. WORLD OF MEDICINE AG
368 NORTH ASAPH STREET
ALEXANDRIA,  VA  22314
Correspondent Contact SUSANNE RAAB
Regulation Number876.1800
Classification Product Code
EXY  
Date Received08/16/2002
Decision Date 08/26/2003
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
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