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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Sensor, Blood-Gas, In-Line, Cardiopulmonary Bypass
510(k) Number K093650
Device Name BIOTREND OXYGEN SATURATION AND HEMATOCRIT SYSTEM
Applicant
MEDTRONIC INC.
8200 Coral Sea Street NE
Mounds View,  MN  55112
Applicant Contact JEFFREY KOLL
Correspondent
MEDTRONIC INC.
8200 Coral Sea Street NE
Mounds View,  MN  55112
Correspondent Contact JEFFREY KOLL
Regulation Number870.4410
Classification Product Code
DTY  
Date Received11/25/2009
Decision Date 02/17/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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