FDA 510(k)

Pulsaderm Acne Mask 28, Pulsaderm Acne Mask 37

K号: K170111 · 2017-05-08

决定日期2017-05-08

产品代码OLP

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决定实质等同

器械摘要

Pulsaderm Acne Mask 28 , Pulsaderm Acne Mask 37 is the device name listed in this FDA 510(k) record. The listed applicant is Pulsaderm, LLC. It received FDA 510(k) clearance on 2017-05-08 under 510(k) number K170111. 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 Pulsaderm Acne Mask 28 , Pulsaderm Acne Mask 37?

Pulsaderm Acne Mask 28 , Pulsaderm Acne Mask 37 is a medical device that received FDA 510(k) clearance on 2017-05-08. The listed applicant is Pulsaderm, LLC. The 510(k) number is K170111.

When did Pulsaderm Acne Mask 28 , Pulsaderm Acne Mask 37 receive FDA 510(k) clearance?

Pulsaderm Acne Mask 28 , Pulsaderm Acne Mask 37 received FDA 510(k) clearance on 2017-05-08, under 510(k) number K170111.

Who is the listed applicant for Pulsaderm Acne Mask 28 , Pulsaderm Acne Mask 37?

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

What is the FDA product code for Pulsaderm Acne Mask 28 , Pulsaderm Acne Mask 37?

The FDA product code for Pulsaderm Acne Mask 28 , Pulsaderm Acne Mask 37 is OLP.

列明Pulsaderm, 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。

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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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