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FDA 510(k)

Straumann Sterile Healing Solution

K号: K161677 · 2016-10-07

决定日期2016-10-07
产品代码NHA
咨询委员会DE
决定Substantially Equivalent

器械摘要

Straumann Sterile Healing Solution is the device name listed in this FDA 510(k) record. The listed applicant is Institut Straumann AG. It received FDA 510(k) clearance on 2016-10-07 under 510(k) number K161677. The device is classified under product code NHA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Straumann Sterile Healing Solution?

Straumann Sterile Healing Solution is a medical device that received FDA 510(k) clearance on 2016-10-07. The listed applicant is Institut Straumann AG. The 510(k) number is K161677.

When did Straumann Sterile Healing Solution receive FDA 510(k) clearance?

Straumann Sterile Healing Solution received FDA 510(k) clearance on 2016-10-07, under 510(k) number K161677.

Who is the listed applicant for Straumann Sterile Healing Solution?

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

What is the FDA product code for Straumann Sterile Healing Solution?

The FDA product code for Straumann Sterile Healing Solution is NHA.

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列明Institut Straumann AG为申报人的其他记录

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相关器械(代码:NHA)

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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