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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 K894756
Device Name DENVER PERITONEO-VENUS SHUNT
Applicant
Codman & Shurtleff, Inc.
41 Pacella Park Dr.
Randolph Industrial Park
Randolph,  MA  02368
Applicant Contact DONALD A LINCOLN
Correspondent
Codman & Shurtleff, Inc.
41 Pacella Park Dr.
Randolph Industrial Park
Randolph,  MA  02368
Correspondent Contact DONALD A LINCOLN
Regulation Number876.5955
Classification Product Code
KPM  
Date Received07/27/1989
Decision Date 09/29/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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