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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Apparatus, Autotransfusion
510(k) Number K991986
Device Name COBE BRAT 2 AUTOLOGOUS BLOOD SALVAGE SYSTEM WITH THE CRIT-LINE HEMATOCRIT SAMPLING SYSTEM OPTION
Applicant
Cobe Cardiovascular, Inc.
14401 W. 65th Way
Arvada,  CO  80004
Applicant Contact LYNNE LEONARD
Correspondent
Cobe Cardiovascular, Inc.
14401 W. 65th Way
Arvada,  CO  80004
Correspondent Contact LYNNE LEONARD
Regulation Number868.5830
Classification Product Code
CAC  
Date Received06/14/1999
Decision Date 09/09/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Hematology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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