MEMO 4D

Ring, Annuloplasty

Sorin Group Italia S.r.l.

The following data is part of a premarket notification filed by Sorin Group Italia S.r.l. with the FDA for Memo 4d.

Pre-market Notification Details

Device IDK180411
510k NumberK180411
Device Name:MEMO 4D
ClassificationRing, Annuloplasty
Applicant Sorin Group Italia S.r.l. Via Crescentino Sn Saluggia,  IT 13040
ContactMauro Ercolani
CorrespondentMauro Ercolani
Sorin Group Italia S.r.l. Via Crescentino Sn Saluggia,  IT 13040
Product CodeKRH  
CFR Regulation Number870.3800 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-02-15
Decision Date2018-03-16
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
08022057015495 K180411 000
08022057015419 K180411 000
08022057015426 K180411 000
08022057015433 K180411 000
08022057015440 K180411 000
08022057015457 K180411 000
08022057015464 K180411 000
08022057015471 K180411 000
08022057015488 K180411 000
08022057015402 K180411 000

Trademark Results [MEMO 4D]

Mark Image

Registration | Serial
Company
Trademark
Application Date
MEMO 4D
MEMO 4D
79217857 5477959 Live/Registered
SORIN GROUP ITALIA S.R.L.
2017-08-25

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