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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 K870855
Device Name UROSCAN
Applicant
ENDOTHERAPEUTICS
191 JEFFERSON DR.
MENLO PARK,  CA  94025
Applicant Contact MOLL, MD
Correspondent
ENDOTHERAPEUTICS
191 JEFFERSON DR.
MENLO PARK,  CA  94025
Correspondent Contact MOLL, MD
Regulation Number876.1620
Classification Product Code
FAP  
Date Received03/03/1987
Decision Date 06/09/1987
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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