GD Disposable Medical Face Mask
K号: K201718 · 2021-04-15
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决定日期2021-04-15
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
GD Disposable Medical Face Mask is the device name listed in this FDA 510(k) record. The listed applicant is Jiangsu Guangda Medical Material Group Co., Ltd.. It received FDA 510(k) clearance on 2021-04-15 under 510(k) number K201718. 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 GD Disposable Medical Face Mask?
GD Disposable Medical Face Mask is a medical device that received FDA 510(k) clearance on 2021-04-15. The listed applicant is Jiangsu Guangda Medical Material Group Co., Ltd.. The 510(k) number is K201718.
When did GD Disposable Medical Face Mask receive FDA 510(k) clearance?
GD Disposable Medical Face Mask received FDA 510(k) clearance on 2021-04-15, under 510(k) number K201718.
Who is the listed applicant for GD Disposable Medical Face Mask?
The FDA 510(k) record lists Jiangsu Guangda Medical Material Group Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for GD Disposable Medical Face Mask?
The FDA product code for GD Disposable Medical Face 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
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