FDA 510(k)

CLEARFIL MAJESTY ES 流体

K号: K191980 · 2019-11-18

决定日期2019-11-18

产品代码EBF

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决定实质等同

器械摘要

CLEARFIL MAJESTY ES Flow is the device name listed in this FDA 510(k) record. The listed applicant is Kuraray Noritake Dental, Inc.. It received FDA 510(k) clearance on 2019-11-18 under 510(k) number K191980. The device is classified under product code EBF. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the CLEARFIL MAJESTY ES Flow?

CLEARFIL MAJESTY ES Flow is a medical device that received FDA 510(k) clearance on 2019-11-18. The listed applicant is Kuraray Noritake Dental, Inc.. The 510(k) number is K191980.

When did CLEARFIL MAJESTY ES Flow receive FDA 510(k) clearance?

CLEARFIL MAJESTY ES Flow received FDA 510(k) clearance on 2019-11-18, under 510(k) number K191980.

Who is the listed applicant for CLEARFIL MAJESTY ES Flow?

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

What is the FDA product code for CLEARFIL MAJESTY ES Flow?

The FDA product code for CLEARFIL MAJESTY ES Flow is EBF.

列明Kuraray Noritake Dental, 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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