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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Reservoir, Blood, Cardiopulmonary Bypass
510(k) Number K843232
Device Name SHILEY HARDSHELL VENOUS RESERVOIR W/INT
Applicant
Shiley, Inc.
17600 Gillette Ave.
Irvine,  CA  92714
Applicant Contact KAREN SALINAS
Correspondent
Shiley, Inc.
17600 Gillette Ave.
Irvine,  CA  92714
Correspondent Contact KAREN SALINAS
Regulation Number870.4400
Classification Product Code
DTN  
Date Received08/17/1984
Decision Date 01/14/1985
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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