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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 K790519
Device Name ULTRALITE UROSYSTEM, MODELS GU-1 & GU-2
Applicant
AMERICAN MEDICAL SYSTEMS, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
AMERICAN MEDICAL SYSTEMS, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number876.1620
Classification Product Code
FAP  
Date Received03/16/1979
Decision Date 05/14/1979
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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