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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cannula, Catheter
510(k) Number K870825
Device Name NEW MODEL STYLES FOR AORTIC ARCH CANNULA
Applicant
Shiley, Inc.
17600 Gillette Ave.
P.O. Box 19503
Irvine,  CA  92714
Applicant Contact MORTON BARAK
Correspondent
Shiley, Inc.
17600 Gillette Ave.
P.O. Box 19503
Irvine,  CA  92714
Correspondent Contact MORTON BARAK
Regulation Number870.1300
Classification Product Code
DQR  
Date Received03/03/1987
Decision Date 03/23/1987
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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