FDA 510(k)

标准顶级灭菌包装

K号: K172207 · 2017-08-25

决定日期2017-08-25

产品代码FRG

咨询委员会医疗设备监管文本翻译如下： HO 请注意，由于您没有提供具体的医疗设备监管文本内容，以上仅为示例。请提供具体的文本内容以便进行准确的翻译。

决定实质等同

器械摘要

Standard Supreme Sterilization Wrapper is the device name listed in this FDA 510(k) record. The listed applicant is Standard Textile Co., Inc.. It received FDA 510(k) clearance on 2017-08-25 under 510(k) number K172207. The device is classified under product code FRG. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Standard Supreme Sterilization Wrapper?

Standard Supreme Sterilization Wrapper is a medical device that received FDA 510(k) clearance on 2017-08-25. The listed applicant is Standard Textile Co., Inc.. The 510(k) number is K172207.

When did Standard Supreme Sterilization Wrapper receive FDA 510(k) clearance?

Standard Supreme Sterilization Wrapper received FDA 510(k) clearance on 2017-08-25, under 510(k) number K172207.

Who is the listed applicant for Standard Supreme Sterilization Wrapper?

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

What is the FDA product code for Standard Supreme Sterilization Wrapper?

The FDA product code for Standard Supreme Sterilization Wrapper is FRG.

列明Standard Textile Co., 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。

K241214ProPel SG3™手术服 K162162Barrier Supreme 消毒包装

相关器械（代码：FRG）

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。

K261897HALYARD* ARMOR-FLEX* 消毒包裹带 ASSURE-DRY* 技术；HALYARD* HEAVY-FLEX* 消毒包裹带 ASSURE-DRY* 技术；HALYARD* STANDARD-FLEX* 消毒包裹带 ASSURE-DRY* 技术；HALYARD* H300W 消毒包裹带 ASSURE-DRY* 技术O&M Halyard, Inc.K252823Dukal 烫金纸灭菌包装Dukal, LLC K253454HALYARD* ONE-STEP* 消毒包裹；HALYARD* QUICK CHECK* 消毒包裹；HALYARD* SEQUENTIAL 消毒包裹；HALYARD* SMART-FOLD* 消毒包裹O&M Halyard, Inc.K251347灭菌袋/卷Sterivic Medical Co., Ltd.K251177自封灭菌袋和卷材Guangdong Maidi Medical Co., Ltd.K250306Chex-All Sterilization Pouches and TubesPropper Manufacturing Co., Inc.

官方来源

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