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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 K113869
Device Name ORIGEN REINFORCED DUAL LUMEN CATHETER
Applicant
Origen Biomedical, Inc.
7000 Burleson Rd. Bldg. D
Austin,  TX  78744
Applicant Contact RICHARD MARTIN
Correspondent
Origen Biomedical, Inc.
7000 Burleson Rd. Bldg. D
Austin,  TX  78744
Correspondent Contact RICHARD MARTIN
Regulation Number870.4210
Classification Product Code
DWF  
Date Received12/30/2011
Decision Date 07/26/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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