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FDA 510(k)

MIPLNI YK-244 Disposable Surgical Mask

K-Number: K210487 · 2021-03-16

ApplicantHunan Yuankang Biological Technology Co., Ltd.
Decision Date2021-03-16
Product CodeFXX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MIPLNI YK-244 Disposable Surgical Mask is a medical device manufactured by Hunan Yuankang Biological Technology Co., Ltd.. It received FDA 510(k) clearance on 2021-03-16 under approval number K210487. The device is classified under product code FXX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MIPLNI YK-244 Disposable Surgical Mask?

MIPLNI YK-244 Disposable Surgical Mask is a medical device that received FDA 510(k) clearance on 2021-03-16. It is manufactured by Hunan Yuankang Biological Technology Co., Ltd.. The 510(k) number is K210487.

When was MIPLNI YK-244 Disposable Surgical Mask approved by the FDA?

MIPLNI YK-244 Disposable Surgical Mask received FDA 510(k) clearance on 2021-03-16, under approval number K210487.

What company makes MIPLNI YK-244 Disposable Surgical Mask?

MIPLNI YK-244 Disposable Surgical Mask is manufactured by Hunan Yuankang Biological Technology Co., Ltd..

What is the FDA product code for MIPLNI YK-244 Disposable Surgical Mask?

The FDA product code for MIPLNI YK-244 Disposable Surgical Mask is FXX.

Related Devices (Code: FXX)

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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.

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