ATS TRI-AD SEMI-FLEXIBLE TRICUSPID ANUULOPLASTY, MODEL 900SFC

Ring, Annuloplasty

Genesee BioMedical, Inc.

The following data is part of a premarket notification filed by Genesee Biomedical, Inc. with the FDA for Ats Tri-ad Semi-flexible Tricuspid Anuuloplasty, Model 900sfc.

Pre-market Notification Details

Device IDK093903
510k NumberK093903
Device Name:ATS TRI-AD SEMI-FLEXIBLE TRICUSPID ANUULOPLASTY, MODEL 900SFC
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 Received2009-12-22
Decision Date2010-07-15
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00643169301108 K093903 000
00643169195356 K093903 000
00643169195363 K093903 000
00643169195370 K093903 000
00643169195387 K093903 000
00643169195394 K093903 000
00643169301061 K093903 000
00643169301078 K093903 000
00643169301085 K093903 000
00643169301092 K093903 000
00643169195349 K093903 000

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.