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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name console, heart-lung machine, cardiopulmonary bypass
510(k) Number K943803
Device Name JOSTRA HL-20 INTEGRATED PERFUSION SYSTEM
Original Applicant
JANUS BIOMEDICAL, INC.
2525 hartford rd.
austin,  TX  78703
Original Contact richard martin
Regulation Number870.4220
Classification Product Code
DTQ  
Date Received08/04/1994
Decision Date 01/30/1996
Decision substantially equivalent (SE)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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