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FDA 510(k) Application Details - K080708
Device Classification Name
Oxygenator, Cardiopulmonary Bypass
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510(K) Number
K080708
Device Name
Oxygenator, Cardiopulmonary Bypass
Applicant
GISH BIOMEDICAL, INC.
11874 SOUTH EVELYN CIRCLE
HOUSTON, TX 77071 US
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Contact
HARVEY KNAUSS
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Regulation Number
870.4350
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Classification Product Code
DTZ
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More FDA Info for this Product Code
Date Received
03/12/2008
Decision Date
02/02/2009
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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