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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ring, Annuloplasty
510(k) Number K792441
Device Name CARPENTIER-EDWARDS FLEX. ANNULOPLASTY
Applicant
EDWARDS LABORATORIES
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
EDWARDS LABORATORIES
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number870.3800
Classification Product Code
KRH  
Date Received11/29/1979
Decision Date 03/17/1980
Decision SE SUBJECT TO TRAKING & PMS (PT)
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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