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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Monitor And/Or Control, Level Sensing, Cardiopulmonary Bypass
510(k) Number K150530
Device Name Level Sensor, Level Sensor Tape
Applicant
Medtronic, Inc.
7611 Northland Dr.
Minneapolis,  MN  55428
Applicant Contact Rahul Shah
Correspondent
Medtronic, Inc.
7611 Northland Dr.
Minneapolis,  MN  55428
Correspondent Contact Rahul Shah
Regulation Number870.4340
Classification Product Code
DTW  
Date Received03/02/2015
Decision Date 05/08/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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