FDA 510(k)

Poly Clear

K号: K183708 · 2019-09-17

决定日期2019-09-17

产品代码OLP

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决定实质等同

器械摘要

Poly Clear is the device name listed in this FDA 510(k) record. The listed applicant is Medtek Skincare, LLC. It received FDA 510(k) clearance on 2019-09-17 under 510(k) number K183708. The device is classified under product code OLP. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Poly Clear?

Poly Clear is a medical device that received FDA 510(k) clearance on 2019-09-17. The listed applicant is Medtek Skincare, LLC. The 510(k) number is K183708.

When did Poly Clear receive FDA 510(k) clearance?

Poly Clear received FDA 510(k) clearance on 2019-09-17, under 510(k) number K183708.

Who is the listed applicant for Poly Clear?

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

What is the FDA product code for Poly Clear?

The FDA product code for Poly Clear is OLP.

列明Medtek Skincare, LLC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。

K180875POLY REJUV

相关器械（代码：OLP）

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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