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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
Applicant
ORIGEN BIOMEDICAL, INC.
2525 HARTFORD RD.
AUSTIN,  TX  78703 -2428
Applicant Contact RICHARD MARTIN
Correspondent
ORIGEN BIOMEDICAL, INC.
2525 HARTFORD RD.
AUSTIN,  TX  78703 -2428
Correspondent 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
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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