FDA 510(k)

Menicon Progent 蛋白质去除剂，用于硬性透气性隐形眼镜

K号: K173136 · 2017-11-16

决定日期2017-11-16

产品代码MRC

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决定实质等同

器械摘要

Menicon Progent Protein Remover for Rigid Gas Permeable Contact Lenses 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 2017-11-16 under 510(k) number K173136. The device is classified under product code MRC. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Menicon Progent Protein Remover for Rigid Gas Permeable Contact Lenses?

Menicon Progent Protein Remover for Rigid Gas Permeable Contact Lenses is a medical device that received FDA 510(k) clearance on 2017-11-16. The listed applicant is Menicon Co, Ltd.. The 510(k) number is K173136.

When did Menicon Progent Protein Remover for Rigid Gas Permeable Contact Lenses receive FDA 510(k) clearance?

Menicon Progent Protein Remover for Rigid Gas Permeable Contact Lenses received FDA 510(k) clearance on 2017-11-16, under 510(k) number K173136.

Who is the listed applicant for Menicon Progent Protein Remover for Rigid Gas Permeable Contact Lenses?

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 Progent Protein Remover for Rigid Gas Permeable Contact Lenses?

The FDA product code for Menicon Progent Protein Remover for Rigid Gas Permeable Contact Lenses is MRC.

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)K191872Menicon 3% 过氧化氢清洁和消毒溶液 K180819One Day Flat Pack (hioxifilcon A) Daily Disposable Soft Contact Lens K180004Menicon ASRB (asmofilcon A) 硅胶软性隐形眼镜

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官方来源

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