ATS SIMULUS SEMI-RIGID MITRAL ANNULOPLASTY RING, MODEL 800SR

Ring, Annuloplasty

Genesee BioMedical, Inc.

The following data is part of a premarket notification filed by Genesee Biomedical, Inc. with the FDA for Ats Simulus Semi-rigid Mitral Annuloplasty Ring, Model 800sr.

Pre-market Notification Details

Device IDK072655
510k NumberK072655
Device Name:ATS SIMULUS SEMI-RIGID MITRAL ANNULOPLASTY RING, MODEL 800SR
ClassificationRing, Annuloplasty
Applicant Genesee BioMedical, Inc. 1308 SOUTH JASON ST. Denver,  CO  80223
ContactJohn T Wright, Ph.d.
CorrespondentJohn T Wright, Ph.d.
Genesee BioMedical, Inc. 1308 SOUTH JASON ST. Denver,  CO  80223
Product CodeKRH  
CFR Regulation Number870.3800 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2007-09-20
Decision Date2007-10-23
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
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00643169182103 K072655 000

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