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FDA 510(k)

EpiFaith Syringe (Luer Slip) , EpiFaith Syringe (NRFit)

K-Number: K182268 · 2019-04-05

ApplicantFlat Medical Co., Ltd.
Decision Date2019-04-05
Product CodeFMF
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

EpiFaith Syringe (Luer Slip) , EpiFaith Syringe (NRFit) is a medical device manufactured by Flat Medical Co., Ltd.. It received FDA 510(k) clearance on 2019-04-05 under approval number K182268. 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 (Luer Slip) , EpiFaith Syringe (NRFit)?

EpiFaith Syringe (Luer Slip) , EpiFaith Syringe (NRFit) is a medical device that received FDA 510(k) clearance on 2019-04-05. It is manufactured by Flat Medical Co., Ltd.. The 510(k) number is K182268.

When was EpiFaith Syringe (Luer Slip) , EpiFaith Syringe (NRFit) approved by the FDA?

EpiFaith Syringe (Luer Slip) , EpiFaith Syringe (NRFit) received FDA 510(k) clearance on 2019-04-05, under approval number K182268.

What company makes EpiFaith Syringe (Luer Slip) , EpiFaith Syringe (NRFit)?

EpiFaith Syringe (Luer Slip) , EpiFaith Syringe (NRFit) is manufactured by Flat Medical Co., Ltd..

What is the FDA product code for EpiFaith Syringe (Luer Slip) , EpiFaith Syringe (NRFit)?

The FDA product code for EpiFaith Syringe (Luer Slip) , EpiFaith Syringe (NRFit) is FMF.

Other Devices by Flat Medical Co., Ltd.

K192421EpiFaith Syringe K212615EpiFaith CV

Related Devices (Code: FMF)

K162180Disposable Insulin SyringeBerpu Medical Technology Co., Ltd. K162081BD 1ml Luer-lok Hypodermic Syringe, BD 1 mL Luer-Lok Hypodermic Syringe with BD Hypodermic Needle or BD Eclipse Hypodermic Needle, BD 1ml Luer-lok Insulin SyringeBecton, Dickinson and Company K162602NovoPen EchoNovo Nordisk, Inc. K161568Bone Solutions Mixing and Delivery SystemBone Solutions, Inc. K152879Sure-Fine Insulin SyringesShina Med Corporation K160629InPenCompanion Medical, Inc.

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.

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