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FDA 510(k) Application Details - K031903
Device Classification Name
Oxygenator, Cardiopulmonary Bypass
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510(K) Number
K031903
Device Name
Oxygenator, Cardiopulmonary Bypass
Applicant
GUIDANT CORPORATION
4100 HAMLINE AVE NORTH
ST PAUL, MN 55112-5798 US
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Contact
STEPHANIE I ROBINSON
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Regulation Number
870.4350
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Classification Product Code
DTZ
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Date Received
06/20/2003
Decision Date
03/03/2004
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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