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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 K010974
Device Name RETROGRADE CARDIOPLEGIA CANNULA, MANUAL-INFLATING, WITH MALLEABLE OR GUIDWIRE STYLET
Original Applicant
CALIFORNIA MEDICAL LABORATORIES, INC.
1570 sunland ln.
costa mesa,  CA  92626
Original Contact mehmet bicakci
Regulation Number870.4210
Classification Product Code
DWF  
Date Received04/02/2001
Decision Date 06/18/2001
Decision substantially equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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