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FDA 510(k)

VSTAAR 调整器

K号: K160278 · 2016-11-04

决定日期2016-11-04
产品代码LXM
决定实质等同

器械摘要

VSTAAR AdjusteR is the device name listed in this FDA 510(k) record. The listed applicant is Spinal Acoustics, LLC. It received FDA 510(k) clearance on 2016-11-04 under 510(k) number K160278. The device is classified under product code LXM. FDA Decision: Substantially Equivalent.

常见问题

What is the VSTAAR AdjusteR?

VSTAAR AdjusteR is a medical device that received FDA 510(k) clearance on 2016-11-04. The listed applicant is Spinal Acoustics, LLC. The 510(k) number is K160278.

When did VSTAAR AdjusteR receive FDA 510(k) clearance?

VSTAAR AdjusteR received FDA 510(k) clearance on 2016-11-04, under 510(k) number K160278.

Who is the listed applicant for VSTAAR AdjusteR?

The FDA 510(k) record lists Spinal Acoustics, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VSTAAR AdjusteR?

The FDA product code for VSTAAR AdjusteR is LXM.

相关临床试验

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相关器械(代码:LXM)

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。

官方来源

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