OTE MPS 045 多用途隐形眼镜护理液
K号: K210051 · 2021-05-26
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决定日期2021-05-26
产品代码LPN
咨询委员会OP
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决定实质等同
器械摘要
OTE MPS 045 Multi-purpose Lens Care Solution is the device name listed in this FDA 510(k) record. The listed applicant is Ote North America, LLC. It received FDA 510(k) clearance on 2021-05-26 under 510(k) number K210051. 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 OTE MPS 045 Multi-purpose Lens Care Solution?
OTE MPS 045 Multi-purpose Lens Care Solution is a medical device that received FDA 510(k) clearance on 2021-05-26. The listed applicant is Ote North America, LLC. The 510(k) number is K210051.
When did OTE MPS 045 Multi-purpose Lens Care Solution receive FDA 510(k) clearance?
OTE MPS 045 Multi-purpose Lens Care Solution received FDA 510(k) clearance on 2021-05-26, under 510(k) number K210051.
Who is the listed applicant for OTE MPS 045 Multi-purpose Lens Care Solution?
The FDA 510(k) record lists Ote North America, LLC as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for OTE MPS 045 Multi-purpose Lens Care Solution?
The FDA product code for OTE MPS 045 Multi-purpose Lens Care Solution is LPN.
相关临床试验
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相关器械（代码：LPN）
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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官方来源
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