ATS SIMULUS ANNULOPLASTY BAND, MODEL 700FC

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 Annuloplasty Band, Model 700fc.

Pre-market Notification Details

Device IDK052899
510k NumberK052899
Device Name:ATS SIMULUS ANNULOPLASTY BAND, MODEL 700FC
ClassificationRing, Annuloplasty
Applicant Genesee BioMedical, Inc. 1308 SOUTH JASON ST. Denver,  CO  80223
ContactJohn T.m. Wright
CorrespondentJohn T.m. Wright
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 Received2005-10-14
Decision Date2005-11-17
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
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