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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Urine Flow Rate Measuring, Non-Electrical, Disposable
510(k) Number K771655
Device Name CURITY PEAKOMETER
Applicant
KENDALL RESEARCH CENTER
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
KENDALL RESEARCH CENTER
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number876.1800
Classification Product Code
FFG  
Date Received08/29/1977
Decision Date 10/14/1977
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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