FDA 510(k)

VALO 大

K号: K160551 · 2016-07-13

决定日期2016-07-13

产品代码EBZ

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决定实质等同

器械摘要

VALO Grand is the device name listed in this FDA 510(k) record. The listed applicant is Ultradent Products, Inc.. It received FDA 510(k) clearance on 2016-07-13 under 510(k) number K160551. The device is classified under product code EBZ. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the VALO Grand?

VALO Grand is a medical device that received FDA 510(k) clearance on 2016-07-13. The listed applicant is Ultradent Products, Inc.. The 510(k) number is K160551.

When did VALO Grand receive FDA 510(k) clearance?

VALO Grand received FDA 510(k) clearance on 2016-07-13, under 510(k) number K160551.

Who is the listed applicant for VALO Grand?

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

What is the FDA product code for VALO Grand?

The FDA product code for VALO Grand is EBZ.

列明Ultradent Products, 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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