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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 K962472
Device Name RUSCH URODYNAMIC RECTAL BALLOON 2-WAY CATHETER
Applicant
Rusch Intl.
Tall Pines Park
Jeffrey,  NH  03452
Applicant Contact NEIL R ARMSTRONG
Correspondent
Rusch Intl.
Tall Pines Park
Jeffrey,  NH  03452
Correspondent Contact NEIL R ARMSTRONG
Regulation Number876.1620
Classification Product Code
FAP  
Date Received06/25/1996
Decision Date 08/27/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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