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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pump, Blood, Cardiopulmonary Bypass, Roller Type
510(k) Number K890904
Device Name MODIFIED STOCKERT-SHILEY CAPS MULTI. ROLLER PUMP
Applicant
Shiley, Inc.
17600 Gillette Ave.
P.O. Box 19503
Irvine,  CA  92714
Applicant Contact MERRITT M GIRGIS
Correspondent
Shiley, Inc.
17600 Gillette Ave.
P.O. Box 19503
Irvine,  CA  92714
Correspondent Contact MERRITT M GIRGIS
Regulation Number870.4370
Classification Product Code
DWB  
Date Received02/10/1989
Decision Date 04/12/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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