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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 K962814
Device Name DENVER PLEURAL EFFUSION SHUNT WITH EXTERNAL PUMP CHAMBER
Applicant
Denver Biomaterials, Inc.
6851 Highway 73
Evergreen,  CO  80439
Applicant Contact LYNNE LEONARD
Correspondent
Denver Biomaterials, Inc.
6851 Highway 73
Evergreen,  CO  80439
Correspondent Contact LYNNE LEONARD
Regulation Number876.5955
Classification Product Code
KPM  
Date Received07/19/1996
Decision Date 04/14/1997
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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