FDA 510(k)

灭菌袋和卷

K号: K242898 · 2025-02-21

申请人Shanghai Jianzhong Medical Packaging Co., Ltd.

决定日期2025-02-21

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

Sterilization Pouches and Reels is the device name listed in this FDA 510(k) record. The listed applicant is Shanghai Jianzhong Medical Packaging Co., Ltd.. It received FDA 510(k) clearance on 2025-02-21 under 510(k) number K242898. 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 Sterilization Pouches and Reels?

Sterilization Pouches and Reels is a medical device that received FDA 510(k) clearance on 2025-02-21. The listed applicant is Shanghai Jianzhong Medical Packaging Co., Ltd.. The 510(k) number is K242898.

When did Sterilization Pouches and Reels receive FDA 510(k) clearance?

Sterilization Pouches and Reels received FDA 510(k) clearance on 2025-02-21, under 510(k) number K242898.

Who is the listed applicant for Sterilization Pouches and Reels?

The FDA 510(k) record lists Shanghai Jianzhong Medical Packaging Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Sterilization Pouches and Reels?

The FDA product code for Sterilization Pouches and Reels is FRG.

列明Shanghai Jianzhong Medical Packaging Co., Ltd.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。

K202341一次性手术口罩

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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