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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name catheter, cannula and tubing, vascular, cardiopulmonary bypass
510(k) Number K002019
Device Name RETROGRADE CARDIOPLEGIA CANNULA, SELF-INFLATING, WITH MALLEABLE OR GUIDEWIRE STYLET
Original Applicant
CALIFORNIA MEDICAL LABORATORIES, INC.
2681 kelvin ave.
irvine,  CA  92614
Original Contact mehmet bicakci
Regulation Number870.4210
Classification Product Code
DWF  
Date Received07/03/2000
Decision Date 03/30/2001
Decision substantially equivalent (SE)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Cardiovascular
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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