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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
Applicant Contact SHERRIN BAKY
Correspondent
American Edwards Laboratories
P.O. Box 11150
17221 Red Hill Ave.(Irvine)
Santa Ana,  CA  92711
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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