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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
510(k) Number K900753
Device Name SHILEY VEIN IRRIGATION CANNULA (BEVELED & BLUNT)
Applicant
Shiley, Inc.
17600 Gillette Ave.
P.O. Box 19503
Irvine,  CA  92714
Applicant Contact ABATI, PH.D
Correspondent
Shiley, Inc.
17600 Gillette Ave.
P.O. Box 19503
Irvine,  CA  92714
Correspondent Contact ABATI, PH.D
Regulation Number870.4210
Classification Product Code
DWF  
Date Received02/16/1990
Decision Date 04/10/1990
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
Recalls CDRH Recalls
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