隐形眼镜,硬性透气,佩戴时间延长
PMA编号:P990018 · 2023-06-16
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决定日期2023-06-16
PMA 编号P990018
产品代码MWL
设备分类第3类
医疗专科O
法规编号21 CFR 8
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。
器械摘要
Lens, contact (rigid gas permeable), extended wear 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 2023-06-16. The device is classified under product code MWL. It was reviewed by the OP advisory panel.
常见问题
What is the Lens, contact (rigid gas permeable), extended wear?
Lens, contact (rigid gas permeable), extended wear is a medical device that received FDA 510(k) clearance on 2023-06-16. The listed applicant is Menicon Co, Ltd..
When did Lens, contact (rigid gas permeable), extended wear receive FDA 510(k) clearance?
The clearance date for Lens, contact (rigid gas permeable), extended wear can be found in the official FDA records.
Who is the listed applicant for Lens, contact (rigid gas permeable), extended wear?
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 Lens, contact (rigid gas permeable), extended wear?
The FDA product code for Lens, contact (rigid gas permeable), extended wear is MWL.
相关临床试验
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。
官方来源
在 FDA 数据库中查看 →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。
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