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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 K970595
Device Name CIRCON ENDOTEK OM-4 H2O CYSTOMETRY PUMP
Applicant
Circon Video
6500 Hollister Ave.
Santa Barbara,  CA  93117
Applicant Contact TODD J POLK
Correspondent
Circon Video
6500 Hollister Ave.
Santa Barbara,  CA  93117
Correspondent Contact TODD J POLK
Regulation Number876.1620
Classification Product Code
FEN  
Subsequent Product Code
EXY  
Date Received02/18/1997
Decision Date 10/24/1997
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
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