FDA 510(k)

Menicon 3% 过氧化氢清洁和消毒溶液

K号: K191872 · 2020-03-02

决定日期2020-03-02

产品代码LPN

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决定实质等同

器械摘要

Menicon 3% Hydrogen Peroxide Cleaning and Disinfecting Solution is the device name listed in this FDA 510(k) record. The listed applicant is Menicon Co, Ltd.. It received FDA 510(k) clearance on 2020-03-02 under 510(k) number K191872. The device is classified under product code LPN. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Menicon 3% Hydrogen Peroxide Cleaning and Disinfecting Solution?

Menicon 3% Hydrogen Peroxide Cleaning and Disinfecting Solution is a medical device that received FDA 510(k) clearance on 2020-03-02. The listed applicant is Menicon Co, Ltd.. The 510(k) number is K191872.

When did Menicon 3% Hydrogen Peroxide Cleaning and Disinfecting Solution receive FDA 510(k) clearance?

Menicon 3% Hydrogen Peroxide Cleaning and Disinfecting Solution received FDA 510(k) clearance on 2020-03-02, under 510(k) number K191872.

Who is the listed applicant for Menicon 3% Hydrogen Peroxide Cleaning and Disinfecting Solution?

FDA 510(k)记录将美尼康株式会社（Menicon Co, Ltd.）列为申请人。这本身并不足以确立该设备的制造商。

What is the FDA product code for Menicon 3% Hydrogen Peroxide Cleaning and Disinfecting Solution?

The FDA product code for Menicon 3% Hydrogen Peroxide Cleaning and Disinfecting Solution is LPN.

列明Menicon Co, Ltd.为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K262495Miru 1day UpSide (midafilcon A)K253795美尼塞普3%过氧化氢清洁与消毒溶液 K193399Miru 1day UpSide (midafilcon A)K180819One Day Flat Pack (hioxifilcon A) Daily Disposable Soft Contact Lens K180004Menicon ASRB (asmofilcon A) 硅胶软性隐形眼镜 K173136Menicon Progent 蛋白质去除剂，用于硬性透气性隐形眼镜

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官方来源

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数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。