FDA 510(k)

Barrier 套筒

K号: K191448 · 2019-10-08

决定日期2019-10-08

产品代码PEM

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决定实质等同

器械摘要

Barrier Sleeves is the device name listed in this FDA 510(k) record. The listed applicant is Ivoclar Vivadent, AG. It received FDA 510(k) clearance on 2019-10-08 under 510(k) number K191448. 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 Barrier Sleeves?

Barrier Sleeves is a medical device that received FDA 510(k) clearance on 2019-10-08. The listed applicant is Ivoclar Vivadent, AG. The 510(k) number is K191448.

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

Barrier Sleeves received FDA 510(k) clearance on 2019-10-08, under 510(k) number K191448.

Who is the listed applicant for Barrier Sleeves?

The FDA 510(k) record lists Ivoclar Vivadent, AG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Barrier Sleeves?

The FDA product code for Barrier Sleeves is PEM.

列明Ivoclar Vivadent, AG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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