FDA 510(k)

Dukal 烫金纸灭菌包装

K号: K252823 · 2026-05-28

决定日期2026-05-28

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

Dukal Crepe Paper Sterilization Wrap is the device name listed in this FDA 510(k) record. The listed applicant is Dukal, LLC. It received FDA 510(k) clearance on 2026-05-28 under 510(k) number K252823. 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 Dukal Crepe Paper Sterilization Wrap?

Dukal Crepe Paper Sterilization Wrap is a medical device that received FDA 510(k) clearance on 2026-05-28. The listed applicant is Dukal, LLC. The 510(k) number is K252823.

When did Dukal Crepe Paper Sterilization Wrap receive FDA 510(k) clearance?

Dukal Crepe Paper Sterilization Wrap received FDA 510(k) clearance on 2026-05-28, under 510(k) number K252823.

Who is the listed applicant for Dukal Crepe Paper Sterilization Wrap?

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

What is the FDA product code for Dukal Crepe Paper Sterilization Wrap?

The FDA product code for Dukal Crepe Paper Sterilization Wrap is FRG.

列明Dukal, 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。

K233262Dukal SMS 灭菌包装

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.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.K243179灭菌袋和卷Yichang Xinxin Paper Products Co., Ltd.

官方来源

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