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FDA 510(k) Application Details - K053021
Device Classification Name
Sucker, Cardiotomy Return, Cardiopulmonary Bypass
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510(K) Number
K053021
Device Name
Sucker, Cardiotomy Return, Cardiopulmonary Bypass
Applicant
ESTECH, INC.
1193 SHERMAN STREET
ALAMEDA, CA 94501 US
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CRAIG COOMBS
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Regulation Number
870.4420
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Classification Product Code
DTS
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Date Received
10/26/2005
Decision Date
01/26/2006
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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