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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
Applicant
JANUS BIOMEDICAL, INC.
2525 HARTFORD RD.
AUSTIN,  TX  78703
Applicant Contact RICHARD MARTIN
Correspondent
JANUS BIOMEDICAL, INC.
2525 HARTFORD RD.
AUSTIN,  TX  78703
Correspondent Contact RICHARD MARTIN
Regulation Number870.4220
Classification Product Code
DTQ  
Date Received08/04/1994
Decision Date 01/30/1996
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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