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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 K943934
Device Name AORTIC ARCH CANNULAS
Original Applicant
CALIFORNIA MEDICAL LABORATORIES, INC.
p.o. box 18470
irvine,  CA  92713
Original Contact mehmet bicakci
Regulation Number870.4210
Classification Product Code
DWF  
Date Received08/12/1994
Decision Date 06/02/1995
Decision substantially equivalent (SE)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
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