Genteel Lancing Device
K-Number: K153670 · 2016-05-12
ApplicantGenteel, LLC
Decision Date2016-05-12
Product CodeFMK
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
Genteel Lancing Device is a medical device manufactured by Genteel, LLC. It received FDA 510(k) clearance on 2016-05-12 under approval number K153670. The device is classified under product code FMK. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Genteel Lancing Device?
Genteel Lancing Device is a medical device that received FDA 510(k) clearance on 2016-05-12. It is manufactured by Genteel, LLC. The 510(k) number is K153670.
When was Genteel Lancing Device approved by the FDA?
Genteel Lancing Device received FDA 510(k) clearance on 2016-05-12, under approval number K153670.
What company makes Genteel Lancing Device?
Genteel Lancing Device is manufactured by Genteel, LLC.
What is the FDA product code for Genteel Lancing Device?
The FDA product code for Genteel Lancing Device is FMK.
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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.