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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Shunt, Peritoneal
510(k) Number K011862
Device Name DENVER ASCITES SHUNT AND PERCUTANEOUS ACCESS KIT WITH ASCITIES SHUNT
Applicant
Denver Biomedical, Inc.
14998 W. 6th Ave., Bldg. E700
Golden,  CO  80401
Applicant Contact BONNIE B VIVIAN
Correspondent
Denver Biomedical, Inc.
14998 W. 6th Ave., Bldg. E700
Golden,  CO  80401
Correspondent Contact BONNIE B VIVIAN
Regulation Number876.5955
Classification Product Code
KPM  
Date Received06/14/2001
Decision Date 07/12/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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