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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name catheter, intravascular, diagnostic
510(k) Number K003288
Device Name ORIGEN DUAL LUMEN CATHETER
Original Applicant
ORIGEN BIOMEDICAL, INC.
2525 hartford rd.
austin,  TX  78703 -2428
Original Contact richard martin
Regulation Number870.1200
Classification Product Code
DQO  
Date Received10/20/2000
Decision Date 06/08/2001
Decision substantially equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
statement statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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