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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 K991170
Device Name RETROGRADE CARDIOPLEGIA CANNULA WITH DURAFLO TREATMENT, MODEL DII-RC-014
Applicant
EDWARDS LIFESCIENCES RESEARCH MEDICAL
6864 SOUTH 300 WEST
MIDVALE,  UT  84047
Applicant Contact JOHN W SMITH
Correspondent
EDWARDS LIFESCIENCES RESEARCH MEDICAL
6864 SOUTH 300 WEST
MIDVALE,  UT  84047
Correspondent Contact JOHN W SMITH
Regulation Number870.4210
Classification Product Code
DWF  
Date Received04/07/1999
Decision Date 07/02/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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