FDA 510(k)

標準至尊消毒包覆材

K 號：K172207 · 2017-08-25

決定日期2017-08-25

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

Standard Supreme Sterilization Wrapper is the device name listed in this FDA 510(k) record. The listed applicant is Standard Textile Co., Inc.. It received FDA 510(k) clearance on 2017-08-25 under 510(k) number K172207. 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 Standard Supreme Sterilization Wrapper?

Standard Supreme Sterilization Wrapper is a medical device that received FDA 510(k) clearance on 2017-08-25. The listed applicant is Standard Textile Co., Inc.. The 510(k) number is K172207.

When did Standard Supreme Sterilization Wrapper receive FDA 510(k) clearance?

Standard Supreme Sterilization Wrapper received FDA 510(k) clearance on 2017-08-25, under 510(k) number K172207.

Who is the listed applicant for Standard Supreme Sterilization Wrapper?

The FDA 510(k) record lists Standard Textile Co., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Standard Supreme Sterilization Wrapper?

The FDA product code for Standard Supreme Sterilization Wrapper is FRG.

其他以 Standard Textile Co., Inc. 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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