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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name defoamer, cardiopulmonary bypass
510(k) Number K002591
Device Name COBE SMARXT VVR 4000 FILTERED HARDSHELL VENOUS RESERVOIR
Applicant
COBE CARDIOVASCULAR, INC.
14401 WEST 65TH WAY
ARVADA,  CO  80004
Applicant Contact LYNNE LEONARD
Correspondent
COBE CARDIOVASCULAR, INC.
14401 WEST 65TH WAY
ARVADA,  CO  80004
Correspondent Contact LYNNE LEONARD
Regulation Number870.4230
Classification Product Code
DTP  
Date Received08/21/2000
Decision Date 09/13/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Special
Reviewed by Third Party No
Combination Product No
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