ATS SIMULUS ADJUSTABLE FLEXIBLE ANNULOPLASTY RING

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 Adjustable Flexible Annuloplasty Ring.

Pre-market Notification Details

Device IDK071214
510k NumberK071214
Device Name:ATS SIMULUS ADJUSTABLE FLEXIBLE ANNULOPLASTY RING
ClassificationRing, Annuloplasty
Applicant Genesee BioMedical, Inc. 1308 SOUTH JASON ST. Denver,  CO  80223
ContactJohn T Wright
CorrespondentJohn T 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 Received2007-05-01
Decision Date2007-07-31
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00643169182486 K071214 000
00643169182479 K071214 000
00643169182462 K071214 000
00643169182455 K071214 000
00643169182448 K071214 000
00643169182431 K071214 000
00643169182295 K071214 000
00643169182219 K071214 000

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