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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 K913728
Device Name DENVER(R) PERITONEO-SUBCLAVIAN SHUNT
Applicant
Denver Biomedicals, Inc.
6851 Hwy. 73
Evergreen,  CO  80439
Applicant Contact SHIRLEY K FREEMAN
Correspondent
Denver Biomedicals, Inc.
6851 Hwy. 73
Evergreen,  CO  80439
Correspondent Contact SHIRLEY K FREEMAN
Regulation Number876.5955
Classification Product Code
KPM  
Date Received08/20/1991
Decision Date 02/18/1994
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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