FDA 510(k)

POLY REJUV

K号: K180875 · 2018-09-14

决定日期2018-09-14

产品代码OHS

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决定实质等同

器械摘要

POLY REJUV 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 2018-09-14 under 510(k) number K180875. The device is classified under product code OHS. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the POLY REJUV?

POLY REJUV is a medical device that received FDA 510(k) clearance on 2018-09-14. The listed applicant is Medtek Skincare, LLC. The 510(k) number is K180875.

When did POLY REJUV receive FDA 510(k) clearance?

POLY REJUV received FDA 510(k) clearance on 2018-09-14, under 510(k) number K180875.

Who is the listed applicant for POLY REJUV?

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 REJUV?

The FDA product code for POLY REJUV is OHS.

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。

K183708Poly Clear

相关器械（代码：OHS）

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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