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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cystometric Gas (Carbon-Dioxide) On Hydraulic Device
510(k) Number K800822
Device Name CO2 CYSTOSCOPY/URETHROSCOPY CONSOLE
Applicant
KLI
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
KLI
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number876.1620
Classification Product Code
FAP  
Date Received04/14/1980
Decision Date 06/17/1980
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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