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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Wire, Guide, Catheter
510(k) Number K960755
Device Name CARDIOTHERM BLOOD CARDIOPLEGIA SYSTEMS
Applicant
Medtronic Cardiac Surgery, Medtronic, Inc.
4633 E. Lapalma Ave.
Anaheim,  CA  92807
Applicant Contact DEBRA KRIDNER
Correspondent
Medtronic Cardiac Surgery, Medtronic, Inc.
4633 E. Lapalma Ave.
Anaheim,  CA  92807
Correspondent Contact DEBRA KRIDNER
Regulation Number870.1330
Classification Product Code
DQX  
Date Received02/23/1996
Decision Date 05/23/1996
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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