FDA 510(k)

DEFEND 耳挂式口罩

K号: K201127 · 2021-04-14

申请人Young Dental Manufacturing Co. 1, LLC

决定日期2021-04-14

产品代码FXX

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决定实质等同

器械摘要

DEFEND Ear-loop Face Masks is the device name listed in this FDA 510(k) record. The listed applicant is Young Dental Manufacturing Co. 1, LLC. It received FDA 510(k) clearance on 2021-04-14 under 510(k) number K201127. 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 DEFEND Ear-loop Face Masks?

DEFEND Ear-loop Face Masks is a medical device that received FDA 510(k) clearance on 2021-04-14. The listed applicant is Young Dental Manufacturing Co. 1, LLC. The 510(k) number is K201127.

When did DEFEND Ear-loop Face Masks receive FDA 510(k) clearance?

DEFEND Ear-loop Face Masks received FDA 510(k) clearance on 2021-04-14, under 510(k) number K201127.

Who is the listed applicant for DEFEND Ear-loop Face Masks?

The FDA 510(k) record lists Young Dental Manufacturing Co. 1, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DEFEND Ear-loop Face Masks?

The FDA product code for DEFEND Ear-loop Face Masks is FXX.

列明Young Dental Manufacturing Co. 1, LLC为申报人的其他记录

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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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。

K251967HALYARD* FLUIDSHIELD* 3 防雾程序口罩，带有 SO SOFT* 内衬和 SO SOFT* 耳带；HALYARD* FLUIDSHIELD* 3 防雾程序口罩，带有 SO SOFT* 内衬和 SO SOFT* 耳带，带有 WrapAround 护目镜O&M Halyard, Inc.K252534Surgical Face Mask (耳挂式)Zhejiang Hangkang Medical Equipment Co., Ltd.K253398一次性手术口罩（非无菌）(EFX3PLBLKMSK300)Efofex, Inc.K252830一次性外科口罩（3P00B，C2900）Beatles Medical Supplies (Xiantao) Co., Ltd.K252650一次性医用口罩Makrite Industries, Inc.K243342KP防护口罩Kp Trading Co., Ltd.

官方来源

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