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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Cystometric, Hydraulic
510(k) Number K952573
Device Name RUSCH URODYNAMIC RECTAL BALLOON 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
FEN  
Date Received06/05/1995
Decision Date 06/15/1995
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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