FDA 510(k)

一次性屏障套筒和盖

K号: K160232 · 2016-06-07

决定日期2016-06-07

产品代码PEM

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决定实质等同

器械摘要

Disposable Barrier Sleeves and Covers is the device name listed in this FDA 510(k) record. The listed applicant is Dentsply International, Inc.. It received FDA 510(k) clearance on 2016-06-07 under 510(k) number K160232. 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 and Covers?

Disposable Barrier Sleeves and Covers is a medical device that received FDA 510(k) clearance on 2016-06-07. The listed applicant is Dentsply International, Inc.. The 510(k) number is K160232.

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

Disposable Barrier Sleeves and Covers received FDA 510(k) clearance on 2016-06-07, under 510(k) number K160232.

Who is the listed applicant for Disposable Barrier Sleeves and Covers?

The FDA 510(k) record lists Dentsply International, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Disposable Barrier Sleeves and Covers?

The FDA product code for Disposable Barrier Sleeves and Covers is PEM.

列明Dentsply International, Inc.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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