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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 K993818
Device Name ANTEGRADE/RETROGRADE PERFUSION ADAPTER WITH OR WITHOUT PRESSURE LINE
Original Applicant
CALIFORNIA MEDICAL LABORATORIES, INC.
2681 kelvin ave.
irvine,  CA  92614
Original Contact mehmet bicakci
Regulation Number870.4210
Classification Product Code
DWF  
Date Received11/10/1999
Decision Date 02/08/2000
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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