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FDA 510(k)

PerfectSmooth

K号: K161428 · 2017-03-23

决定日期2017-03-23
产品代码OHT
咨询委员会SU 请注意,您提供的文本“SU”不足以进行翻译。请提供完整的描述性文本以便进行翻译。
决定实质等同

器械摘要

PerfectSmooth is the device name listed in this FDA 510(k) record. The listed applicant is Shen Zhen Cosbeauty Co., Ltd.. It received FDA 510(k) clearance on 2017-03-23 under 510(k) number K161428. The device is classified under product code OHT. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the PerfectSmooth?

PerfectSmooth is a medical device that received FDA 510(k) clearance on 2017-03-23. The listed applicant is Shen Zhen Cosbeauty Co., Ltd.. The 510(k) number is K161428.

When did PerfectSmooth receive FDA 510(k) clearance?

PerfectSmooth received FDA 510(k) clearance on 2017-03-23, under 510(k) number K161428.

Who is the listed applicant for PerfectSmooth?

The FDA 510(k) record lists Shen Zhen Cosbeauty Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PerfectSmooth?

The FDA product code for PerfectSmooth is OHT.

相关临床试验

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列明Shen Zhen Cosbeauty Co., Ltd.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。

相关器械(代码:OHT)

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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