FDA 510(k)

一次性屏障套筒

K号: K220662 · 2022-05-11

决定日期2022-05-11

产品代码PEM

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决定实质等同

器械摘要

Disposable Barrier Sleeves is the device name listed in this FDA 510(k) record. The listed applicant is Premium Plus (Dongguan) Limited. It received FDA 510(k) clearance on 2022-05-11 under 510(k) number K220662. The device is classified under product code PEM. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Disposable Barrier Sleeves?

Disposable Barrier Sleeves is a medical device that received FDA 510(k) clearance on 2022-05-11. The listed applicant is Premium Plus (Dongguan) Limited. The 510(k) number is K220662.

When did Disposable Barrier Sleeves receive FDA 510(k) clearance?

Disposable Barrier Sleeves received FDA 510(k) clearance on 2022-05-11, under 510(k) number K220662.

Who is the listed applicant for Disposable Barrier Sleeves?

The FDA 510(k) record lists Premium Plus (Dongguan) Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Disposable Barrier Sleeves?

The FDA product code for Disposable Barrier Sleeves is PEM.

列明Premium Plus (Dongguan) Limited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。

K251869一次性预防性角度（3399-60，3399-090，3399-105）K250009LED固化灯（C01-X，C02-X）

官方来源

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