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FDA 510(k) Application Details - K002591
Device Classification Name
Defoamer, Cardiopulmonary Bypass
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510(K) Number
K002591
Device Name
Defoamer, Cardiopulmonary Bypass
Applicant
COBE CARDIOVASCULAR, INC.
14401 WEST 65TH WAY
ARVADA, CO 80004 US
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Contact
LYNNE LEONARD
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Regulation Number
870.4230
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Classification Product Code
DTP
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More FDA Info for this Product Code
Date Received
08/21/2000
Decision Date
09/13/2000
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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