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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 K881074
Device Name SHILEY FEMORAL VENOUS CANNULA
Applicant
Shiley, Inc.
17600 Gillette Ave.
P.O. Box 19503
Irvine,  CA  92714
Applicant Contact RADINE POBUDA
Correspondent
Shiley, Inc.
17600 Gillette Ave.
P.O. Box 19503
Irvine,  CA  92714
Correspondent Contact RADINE POBUDA
Regulation Number870.4210
Classification Product Code
DWF  
Date Received03/14/1988
Decision Date 05/31/1988
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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