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FDA 510(k)

Acuity 85 (奥普非孔素A) 硬性透气性隐形眼镜

K号: K170001 · 2017-06-02

决定日期2017-06-02
产品代码HQD
咨询委员会OP 请注意,由于您没有提供具体的医疗设备监管文本,我无法进行翻译。请提供具体的文本内容,以便我能够按照您的要求进行翻译。
决定实质等同

器械摘要

Acuity 85 (Oprifocon A) Rigid Gas Permeable Contact Lens is the device name listed in this FDA 510(k) record. The listed applicant is Acuity Polymers, Inc.. It received FDA 510(k) clearance on 2017-06-02 under 510(k) number K170001. The device is classified under product code HQD. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Acuity 85 (Oprifocon A) Rigid Gas Permeable Contact Lens?

Acuity 85 (Oprifocon A) Rigid Gas Permeable Contact Lens is a medical device that received FDA 510(k) clearance on 2017-06-02. The listed applicant is Acuity Polymers, Inc.. The 510(k) number is K170001.

When did Acuity 85 (Oprifocon A) Rigid Gas Permeable Contact Lens receive FDA 510(k) clearance?

Acuity 85 (Oprifocon A) Rigid Gas Permeable Contact Lens received FDA 510(k) clearance on 2017-06-02, under 510(k) number K170001.

Who is the listed applicant for Acuity 85 (Oprifocon A) Rigid Gas Permeable Contact Lens?

The FDA 510(k) record lists Acuity Polymers, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Acuity 85 (Oprifocon A) Rigid Gas Permeable Contact Lens?

The FDA product code for Acuity 85 (Oprifocon A) Rigid Gas Permeable Contact Lens is HQD.

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列明Acuity Polymers, Inc.为申报人的其他记录

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相关器械(代码:HQD)

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。

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