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FDA 510(k) Application Details - K150542
Device Classification Name
Tubing, Pump, Cardiopulmonary Bypass
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510(K) Number
K150542
Device Name
Tubing, Pump, Cardiopulmonary Bypass
Applicant
TERUMO CARDIOVASCULAR SYSTEMS CORPORATION
28 HOWE STREET
ASHLAND, MA 01721 US
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JOSHUA EWING
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Regulation Number
870.4390
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Classification Product Code
DWE
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Date Received
03/03/2015
Decision Date
05/01/2015
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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