FDA 510(k)

一次性手术隔离服

K号: K212422 · 2022-04-29

申请人Crown Name Disposable Hygiene Products Fty., Ltd.

决定日期2022-04-29

产品代码FYC

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决定实质等同

器械摘要

Disposable Surgical Isolation Gown is the device name listed in this FDA 510(k) record. The listed applicant is Crown Name Disposable Hygiene Products Fty., Ltd.. It received FDA 510(k) clearance on 2022-04-29 under 510(k) number K212422. The device is classified under product code FYC. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Disposable Surgical Isolation Gown?

Disposable Surgical Isolation Gown is a medical device that received FDA 510(k) clearance on 2022-04-29. The listed applicant is Crown Name Disposable Hygiene Products Fty., Ltd.. The 510(k) number is K212422.

When did Disposable Surgical Isolation Gown receive FDA 510(k) clearance?

Disposable Surgical Isolation Gown received FDA 510(k) clearance on 2022-04-29, under 510(k) number K212422.

Who is the listed applicant for Disposable Surgical Isolation Gown?

The FDA 510(k) record lists Crown Name Disposable Hygiene Products Fty., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Disposable Surgical Isolation Gown?

The FDA product code for Disposable Surgical Isolation Gown is FYC.

列明Crown Name Disposable Hygiene Products Fty., Ltd.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。

K203534外科口罩（型号：平面耳钩/CN102）

相关器械（代码：FYC）

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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