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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
Applicant
CALIFORNIA MEDICAL LABORATORIES, INC.
2681 kelvin ave.
irvine,  CA  92614
Applicant Contact mehmet bicakci
Correspondent
CALIFORNIA MEDICAL LABORATORIES, INC.
2681 kelvin ave.
irvine,  CA  92614
Correspodent Contact mehmet bicakci
Regulation Number870.4210
Classification Product Code
DWF  
Date Received07/03/2000
Decision Date 03/30/2001
Decision substantially equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
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