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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
Applicant
CALIFORNIA MEDICAL LABORATORIES, INC.
P.O. BOX 18470
IRVINE,  CA  92713
Applicant Contact MEHMET BICAKCI
Correspondent
CALIFORNIA MEDICAL LABORATORIES, INC.
P.O. BOX 18470
IRVINE,  CA  92713
Correspondent Contact MEHMET BICAKCI
Regulation Number870.4210
Classification Product Code
DWF  
Date Received08/12/1994
Decision Date 06/02/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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