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FDA 510(k)

安全穩定之蒸汽及乙氧基過程消毒包袋指示標誌

K 號：K153540 · 2016-08-04

申請人Safe Secure Packaging Co., Ltd.
決定日期2016-08-04
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

Safe Secure Sterilization Pouch with Steam and Ethylene Oxide Process Indicators is the device name listed in this FDA 510(k) record. The listed applicant is Safe Secure Packaging Co., Ltd.. It received FDA 510(k) clearance on 2016-08-04 under 510(k) number K153540. 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 Safe Secure Sterilization Pouch with Steam and Ethylene Oxide Process Indicators?

Safe Secure Sterilization Pouch with Steam and Ethylene Oxide Process Indicators is a medical device that received FDA 510(k) clearance on 2016-08-04. The listed applicant is Safe Secure Packaging Co., Ltd.. The 510(k) number is K153540.

When did Safe Secure Sterilization Pouch with Steam and Ethylene Oxide Process Indicators receive FDA 510(k) clearance?

Safe Secure Sterilization Pouch with Steam and Ethylene Oxide Process Indicators received FDA 510(k) clearance on 2016-08-04, under 510(k) number K153540.

Who is the listed applicant for Safe Secure Sterilization Pouch with Steam and Ethylene Oxide Process Indicators?

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

What is the FDA product code for Safe Secure Sterilization Pouch with Steam and Ethylene Oxide Process Indicators?

The FDA product code for Safe Secure Sterilization Pouch with Steam and Ethylene Oxide Process Indicators is FRG.

相關臨床試驗

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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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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