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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tubing, Pump, Cardiopulmonary Bypass
510(k) Number K981613
Device Name COBE SMARXT TUBING AND CONNECTORS
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 Number870.4390
Classification Product Code
DWE  
Date Received05/06/1998
Decision Date 10/26/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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