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

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 800sc.

Pre-market Notification Details

Device IDK083683
510k NumberK083683
Device Name:ATS SIMULUS SEMI-RIGID MITRAL ANNULOPLASTY RING, MODEL 800SC
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 Received2008-12-12
Decision Date2009-02-25

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00643169300934 K083683 000
00643169182134 K083683 000
00643169182141 K083683 000
00643169182158 K083683 000
00643169182165 K083683 000
00643169182172 K083683 000
00643169182189 K083683 000
00643169182196 K083683 000
00643169182202 K083683 000
00643169300880 K083683 000
00643169300897 K083683 000
00643169300903 K083683 000
00643169300910 K083683 000
00643169300927 K083683 000
00643169182127 K083683 000

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