FDA 510(k)

Anprolene AN75环氧乙烷气体灭菌器

K号: K170432 · 2017-10-31

决定日期2017-10-31

产品代码FLF

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决定实质等同

器械摘要

Anprolene AN75 Ethylene Oxide Gas Sterilizer is the device name listed in this FDA 510(k) record. The listed applicant is Andersen Sterilizers, Inc.. It received FDA 510(k) clearance on 2017-10-31 under 510(k) number K170432. The device is classified under product code FLF. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Anprolene AN75 Ethylene Oxide Gas Sterilizer?

Anprolene AN75 Ethylene Oxide Gas Sterilizer is a medical device that received FDA 510(k) clearance on 2017-10-31. The listed applicant is Andersen Sterilizers, Inc.. The 510(k) number is K170432.

When did Anprolene AN75 Ethylene Oxide Gas Sterilizer receive FDA 510(k) clearance?

Anprolene AN75 Ethylene Oxide Gas Sterilizer received FDA 510(k) clearance on 2017-10-31, under 510(k) number K170432.

Who is the listed applicant for Anprolene AN75 Ethylene Oxide Gas Sterilizer?

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

What is the FDA product code for Anprolene AN75 Ethylene Oxide Gas Sterilizer?

The FDA product code for Anprolene AN75 Ethylene Oxide Gas Sterilizer is FLF.

列明Andersen Sterilizers, Inc.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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