FDA 510(k)

Atteris 无痛皮肤保护剂

K号: K160684 · 2016-07-26

决定日期2016-07-26

产品代码KMF

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决定实质等同

器械摘要

Atteris No-Sting Skin Protectant is the device name listed in this FDA 510(k) record. The listed applicant is Rochal Industries, LLC. It received FDA 510(k) clearance on 2016-07-26 under 510(k) number K160684. The device is classified under product code KMF. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Atteris No-Sting Skin Protectant?

Atteris No-Sting Skin Protectant is a medical device that received FDA 510(k) clearance on 2016-07-26. The listed applicant is Rochal Industries, LLC. The 510(k) number is K160684.

When did Atteris No-Sting Skin Protectant receive FDA 510(k) clearance?

Atteris No-Sting Skin Protectant received FDA 510(k) clearance on 2016-07-26, under 510(k) number K160684.

Who is the listed applicant for Atteris No-Sting Skin Protectant?

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

What is the FDA product code for Atteris No-Sting Skin Protectant?

The FDA product code for Atteris No-Sting Skin Protectant is KMF.

列明Rochal Industries, 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。

K192527Rochal抗菌伤口凝胶 K182733Rochal生物防护硅酮薄膜 K161212Atteris 抗菌皮肤保护剂 K160192Atteris 抗菌皮肤和伤口清洁剂

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