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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 K823561
Device Name URETHRAL PRESSURE PROFILE & TEMP. MODUL
Applicant
NIHON KOHDEN AMERICA, INC.
90 ICON ST.
FOOTHILL RANCH,  CA  92610 -1601
Correspondent
NIHON KOHDEN AMERICA, INC.
90 ICON ST.
FOOTHILL RANCH,  CA  92610 -1601
Regulation Number876.1620
Classification Product Code
FAP  
Date Received12/02/1982
Decision Date 01/07/1983
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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