NeoForm Annuloplasty Ring
K-Number: K190506 · 2019-04-18
ApplicantGenesee Biomedical, Inc.
Decision Date2019-04-18
Product CodeKRH
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
NeoForm Annuloplasty Ring is a medical device manufactured by Genesee Biomedical, Inc.. It received FDA 510(k) clearance on 2019-04-18 under approval number K190506. The device is classified under product code KRH. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the NeoForm Annuloplasty Ring?
NeoForm Annuloplasty Ring is a medical device that received FDA 510(k) clearance on 2019-04-18. It is manufactured by Genesee Biomedical, Inc.. The 510(k) number is K190506.
When was NeoForm Annuloplasty Ring approved by the FDA?
NeoForm Annuloplasty Ring received FDA 510(k) clearance on 2019-04-18, under approval number K190506.
What company makes NeoForm Annuloplasty Ring?
NeoForm Annuloplasty Ring is manufactured by Genesee Biomedical, Inc..
What is the FDA product code for NeoForm Annuloplasty Ring?
The FDA product code for NeoForm Annuloplasty Ring is KRH.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.