FDA 510(k)

DenMat Glutaraldehyde Desensitizer

K号: K222357 · 2022-08-09

决定日期2022-08-09

产品代码KLE

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决定实质等同

器械摘要

DenMat Glutaraldehyde Desensitizer is the device name listed in this FDA 510(k) record. The listed applicant is Denmat Holding, LLC. It received FDA 510(k) clearance on 2022-08-09 under 510(k) number K222357. The device is classified under product code KLE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the DenMat Glutaraldehyde Desensitizer?

DenMat Glutaraldehyde Desensitizer is a medical device that received FDA 510(k) clearance on 2022-08-09. The listed applicant is Denmat Holding, LLC. The 510(k) number is K222357.

When did DenMat Glutaraldehyde Desensitizer receive FDA 510(k) clearance?

DenMat Glutaraldehyde Desensitizer received FDA 510(k) clearance on 2022-08-09, under 510(k) number K222357.

Who is the listed applicant for DenMat Glutaraldehyde Desensitizer?

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

What is the FDA product code for DenMat Glutaraldehyde Desensitizer?

The FDA product code for DenMat Glutaraldehyde Desensitizer is KLE.

列明Denmat Holding, 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。

K251593DenMat Multilayered Zirconia Disc

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