EpiFaith Syringe
K-Number: K192421 · 2019-09-27
ApplicantFlat Medical Co., Ltd.
Decision Date2019-09-27
Product CodeFMF
Advisory CommitteeHO
DecisionSubstantially Equivalent
Device Summary
EpiFaith Syringe is a medical device manufactured by Flat Medical Co., Ltd.. It received FDA 510(k) clearance on 2019-09-27 under approval number K192421. The device is classified under product code FMF. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the EpiFaith Syringe?
EpiFaith Syringe is a medical device that received FDA 510(k) clearance on 2019-09-27. It is manufactured by Flat Medical Co., Ltd.. The 510(k) number is K192421.
When was EpiFaith Syringe approved by the FDA?
EpiFaith Syringe received FDA 510(k) clearance on 2019-09-27, under approval number K192421.
What company makes EpiFaith Syringe?
EpiFaith Syringe is manufactured by Flat Medical Co., Ltd..
What is the FDA product code for EpiFaith Syringe?
The FDA product code for EpiFaith Syringe is FMF.
Other Devices by Flat Medical Co., Ltd.
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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.