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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 K894794
Device Name AGISHI ASCITES PUMP PERITONEOCAVAL SHUNT PUMP
Applicant
Vitaid, Ltd.
147 Old Orchard Grove
Toronto, Ontario, Canada
M5m 2e1,  CA
Applicant Contact G STEWART
Correspondent
Vitaid, Ltd.
147 Old Orchard Grove
Toronto, Ontario, Canada
M5m 2e1,  CA
Correspondent Contact G STEWART
Regulation Number876.5955
Classification Product Code
KPM  
Date Received07/28/1989
Decision Date 11/21/1989
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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