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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 K011020
Device Name DENVER PLEURAL EFFUSION SHUNT WITH EXTERNAL PUMP CHAMBER
Applicant
Denver Biomedicals, Inc.
401 Spruce St.
Louisville,  CO  80027
Applicant Contact NANCY SAUER
Correspondent
Denver Biomedicals, Inc.
401 Spruce St.
Louisville,  CO  80027
Correspondent Contact NANCY SAUER
Regulation Number876.5955
Classification Product Code
KPM  
Date Received04/04/2001
Decision Date 06/01/2001
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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