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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Oxygenator, Cardiopulmonary Bypass
510(k) Number K926467
Device Name COBE CMS-FS MEMBRANE OXYGENATOR
Applicant
COBE CARDIOVASCULAR, INC.
14401 WEST 65TH WAY
ARVADA,  CO  80004
Applicant Contact BEN BRIAN
Correspondent
COBE CARDIOVASCULAR, INC.
14401 WEST 65TH WAY
ARVADA,  CO  80004
Correspondent Contact BEN BRIAN
Regulation Number870.4350
Classification Product Code
DTZ  
Date Received12/28/1992
Decision Date 11/09/1993
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
Recalls CDRH Recalls
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