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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Holder, Heart-Valve, Prosthesis
510(k) Number K864155
Device Name MODIFICATION OF CARPENTIER-EDWARDS BIOPROSTHESIS
Applicant
AMERICAN EDWARDS LABORATORIES
P.O. BOX 11150
17221 RED HILL AVE.(IRVINE)
SANTA ANA,  CA  92711 -1150
Applicant Contact SHERRIN BAKY
Correspondent
AMERICAN EDWARDS LABORATORIES
P.O. BOX 11150
17221 RED HILL AVE.(IRVINE)
SANTA ANA,  CA  92711 -1150
Correspondent Contact SHERRIN BAKY
Regulation Number870.3935
Classification Product Code
DTJ  
Date Received10/23/1986
Decision Date 11/20/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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