SJM ATTUNE ANNULOPLASTY RING

Ring, Annuloplasty

ST. JUDE MEDICAL

The following data is part of a premarket notification filed by St. Jude Medical with the FDA for Sjm Attune Annuloplasty Ring.

Pre-market Notification Details

Device IDK092876
510k NumberK092876
Device Name:SJM ATTUNE ANNULOPLASTY RING
ClassificationRing, Annuloplasty
Applicant ST. JUDE MEDICAL 177 EAST COUNTY ROAD B St. Paul,  MN  55117
ContactThomas Tademacher
CorrespondentThomas Tademacher
ST. JUDE MEDICAL 177 EAST COUNTY ROAD B St. Paul,  MN  55117
Product CodeKRH  
CFR Regulation Number870.3800 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2009-09-18
Decision Date2009-10-16
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
05414734052177 K092876 000
05414734029964 K092876 000
05414734029971 K092876 000
05414734029988 K092876 000
05414734029995 K092876 000
05414734030007 K092876 000
05414734052146 K092876 000
05414734052153 K092876 000
05414734052160 K092876 000
05414734029957 K092876 000

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