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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 K981601
Device Name CALIFORNIA MEDICAL LABORATORIES INC. MALLEABLE VENT CATHETER
Original Applicant
CALIFORNIA MEDICAL LABORATORIES, INC.
2681 kelvin ave.
irvine,  CA  92614
Original Contact mehmet bicakci
Regulation Number870.4210
Classification Product Code
DWF  
Date Received05/04/1998
Decision Date 07/28/1998
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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