Freudenberg外科口罩
K号: K210063 · 2021-02-05
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决定日期2021-02-05
产品代码FXX
咨询委员会SU
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决定实质等同
器械摘要
Freudenberg Surgical Mask is the device name listed in this FDA 510(k) record. The listed applicant is Freudenberg Performance Materials LP. It received FDA 510(k) clearance on 2021-02-05 under 510(k) number K210063. The device is classified under product code FXX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Freudenberg Surgical Mask?
Freudenberg Surgical Mask is a medical device that received FDA 510(k) clearance on 2021-02-05. The listed applicant is Freudenberg Performance Materials LP. The 510(k) number is K210063.
When did Freudenberg Surgical Mask receive FDA 510(k) clearance?
Freudenberg Surgical Mask received FDA 510(k) clearance on 2021-02-05, under 510(k) number K210063.
Who is the listed applicant for Freudenberg Surgical Mask?
The FDA 510(k) record lists Freudenberg Performance Materials LP as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Freudenberg Surgical Mask?
The FDA product code for Freudenberg Surgical Mask is FXX.
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。
相关器械（代码：FXX）
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
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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