FDA 510(k)

消毒包及卷

K 號：K242898 · 2025-02-21

申請人Shanghai Jianzhong Medical Packaging Co., Ltd.

決定日期2025-02-21

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

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.

常見問題

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.

其他以 Shanghai Jianzhong Medical Packaging Co., Ltd. 為申請人之記錄

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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。

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官方來源

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