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FDA 510(k) Application Details - K020365
Device Classification Name
Accessory Equipment, Cardiopulmonary Bypass
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510(K) Number
K020365
Device Name
Accessory Equipment, Cardiopulmonary Bypass
Applicant
3T MEDICAL SYSTEMS, LLC.
12553 S. WAMBLEE VALLEY RD.
CONIFER, CO 80433-6204 US
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Contact
ROBERT P EATON
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Regulation Number
870.4200
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Classification Product Code
KRI
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More FDA Info for this Product Code
Date Received
02/04/2002
Decision Date
05/03/2002
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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