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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 K180411
Device Name MEMO 4D
Applicant
Sorin Group Italia S.R.L.
Via Crescentino Sn
Saluggia,  IT 13040
Applicant Contact Mauro Ercolani
Correspondent
Sorin Group Italia S.R.L.
Via Crescentino Sn
Saluggia,  IT 13040
Correspondent Contact Mauro Ercolani
Regulation Number870.3800
Classification Product Code
KRH  
Date Received02/15/2018
Decision Date 03/16/2018
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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