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FDA 510(k) Application Details - K081881
Device Classification Name
Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
More FDA Info for this Device
510(K) Number
K081881
Device Name
Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Applicant
GISH BIOMEDICAL, INC.
22942 ARROYO VISTA
RANCHO SANTA MARGARITA, CA 92688 US
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Contact
EDWARD F WADDELL
Other 510(k) Applications for this Contact
Regulation Number
870.4210
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Classification Product Code
DWF
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More FDA Info for this Product Code
Date Received
07/02/2008
Decision Date
01/23/2009
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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