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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 K990396
Device Name T-ANASTAFLO
Original Applicant
EDWARDS LIFESCIENCES RESEARCH MEDICAL
6864 south 300 west
midvale,  UT  84047
Original Contact john w smith
Regulation Number870.4210
Classification Product Code
DWF  
Date Received02/09/1999
Decision Date 10/01/1999
Decision substantially equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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