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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 K003451
Device Name DENVER PAK W/ DOUBLE-VALVE ASCITES SHUNT,DENVER PAK W/ SINGLE-VALVED ASCITES SHUNT, DENVER PAK, DOUBLED-VALVED ASCITES T
Applicant
Denver Biomedicals, Inc.
14998 W. 6th Ave., Bldg. E700
Golden,  CO  80401
Applicant Contact BONNIE VIVIAN
Correspondent
Denver Biomedicals, Inc.
14998 W. 6th Ave., Bldg. E700
Golden,  CO  80401
Correspondent Contact BONNIE VIVIAN
Regulation Number876.5955
Classification Product Code
KPM  
Date Received11/07/2000
Decision Date 01/02/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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