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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 K945065
Device Name DIDECO FLEXIBLE RESERVOIR -- PRODUCT DESIGNATION 5063
Applicant
SORIN BIOMEDICAL, INC.
17600 GILLETTE AVE.
P.O. BOX 19503
IRVINE,  CA  92713 -9503
Applicant Contact RONALD S WARREN
Correspondent
SORIN BIOMEDICAL, INC.
17600 GILLETTE AVE.
P.O. BOX 19503
IRVINE,  CA  92713 -9503
Correspondent Contact RONALD S WARREN
Regulation Number870.4400
Classification Product Code
DTN  
Date Received10/14/1994
Decision Date 05/19/1995
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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