FDA 510(k)

杜卡爾克雷佩紙消毒包覆材

K 號：K252823 · 2026-05-28

決定日期2026-05-28

產品代碼FRG

諮詢委員會醫療設備規範文本翻譯如下： HO 注意：原文中未提供具體的醫療設備規範文本，因此上述翻譯僅為示例。請提供完整的規範文本以便進行準確翻譯。

決定相當於

器材摘要

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.

常見問題

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.

其他以 Dukal, LLC 為申請人之記錄

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K233262杜卡爾 SMS 過濾包

相關器械（代碼：FRG）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K261897HALYARD* ARMOR-FLEX* 過濾包裝帶，配備ASSURE-DRY* 技術；HALYARD* HEAVY-FLEX* 過濾包裝帶，配備ASSURE-DRY* 技術；HALYARD* STANDARD-FLEX* 過濾包裝帶，配備ASSURE-DRY* 技術；HALYARD* H300W 過濾包裝帶，配備ASSURE-DRY* 技術O&M Halyard, Inc.K253454HALYARD* 一步式* 消毒包材；HALYARD* 快速檢查* 消毒包材；HALYARD* 逐序* 消毒包材；HALYARD* 智能折* 消毒包材O&M Halyard, Inc.K251347消毒袋/卷Sterivic Medical Co., Ltd.K251177自封式消毒袋及卷材Guangdong Maidi Medical Co., Ltd.K250306Chex-All 過濾包及管子Propper Manufacturing Co., Inc.K243179消毒袋及卷材Yichang Xinxin Paper Products Co., Ltd.

官方來源

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