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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name valvulotome
510(k) Number K001734
Device Name FOGARTY VALVULOTOME, MODEL 700091
Applicant
EDWARDS LIFESCIENCES, LLC.
ONE EDWARDS WAY
IRVINE,  CA  92614
Applicant Contact DIANE PETERSON
Correspondent
EDWARDS LIFESCIENCES, LLC.
ONE EDWARDS WAY
IRVINE,  CA  92614
Correspondent Contact DIANE PETERSON
Regulation Number870.4885
Classification Product Code
MGZ  
Date Received06/07/2000
Decision Date 03/26/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
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