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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 K854841
Device Name SHILEY VENOUS RESERVOIR
Applicant
SHILEY, INC.
17600 GILLETTE AVE.
P.O. BOX 19503
IRVINE,  CA  92714
Applicant Contact DAVID THOMAS
Correspondent
SHILEY, INC.
17600 GILLETTE AVE.
P.O. BOX 19503
IRVINE,  CA  92714
Correspondent Contact DAVID THOMAS
Regulation Number870.4400
Classification Product Code
DTN  
Date Received12/04/1985
Decision Date 02/10/1986
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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