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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name console, heart-lung machine, cardiopulmonary bypass
510(k) Number K942582
Device Name SORIN BLOOD CARDIOPLEGIA CONSOLE
Applicant
SORIN BIOMEDICAL, INC.
17600 GILLETTE AVE.
P.O. BOX 19503
IRVINE,  CA  92614 -5751
Applicant Contact RONALD S WARREN
Correspondent
SORIN BIOMEDICAL, INC.
17600 GILLETTE AVE.
P.O. BOX 19503
IRVINE,  CA  92614 -5751
Correspondent Contact RONALD S WARREN
Regulation Number870.4220
Classification Product Code
DTQ  
Date Received06/01/1994
Decision Date 01/27/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
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