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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name urinometer, mechanical
510(k) Number K896732
Device Name UNOMETER 500
Applicant
UNOPLAST A/S
DK-3390 HUNDESTED
DENMARK,  DK
Applicant Contact ERIK ANDERSEN
Correspondent
UNOPLAST A/S
DK-3390 HUNDESTED
DENMARK,  DK
Correspondent Contact ERIK ANDERSEN
Regulation Number876.1800
Classification Product Code
EXR  
Date Received11/30/1989
Decision Date 11/02/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
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