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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 K142221
Device Name MEMO 3D ReChord
Applicant
Sorin Group Italia S.R.L.
Via Crescentino Sn
Saluggia Vercelli,  IT 13040
Applicant Contact MAURO ERCOLANI
Correspondent
Sorin Group Canada, Inc.
5005 N. Fraser Way
Burnaby, British Columbia,  CA V5J 5M1
Correspondent Contact FABIO DE PASQUALE
Regulation Number870.3800
Classification Product Code
KRH  
Date Received08/12/2014
Decision Date 08/29/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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