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FDA 510(k)

PMSSteripack 平面消毒包 (FP) 及卷筒 (FL) 配化學指示劑

K 號：K162362 · 2017-10-13

申請人Pms Tibbi Cihazlar Teknolojisi San VE Tic AS
決定日期2017-10-13
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

PMSSteripack Flat Sterilization Pouch (FP) and Roll (FL) with Chemical Indicator is the device name listed in this FDA 510(k) record. The listed applicant is Pms Tibbi Cihazlar Teknolojisi San VE Tic AS. It received FDA 510(k) clearance on 2017-10-13 under 510(k) number K162362. 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 PMSSteripack Flat Sterilization Pouch (FP) and Roll (FL) with Chemical Indicator?

PMSSteripack Flat Sterilization Pouch (FP) and Roll (FL) with Chemical Indicator is a medical device that received FDA 510(k) clearance on 2017-10-13. The listed applicant is Pms Tibbi Cihazlar Teknolojisi San VE Tic AS. The 510(k) number is K162362.

When did PMSSteripack Flat Sterilization Pouch (FP) and Roll (FL) with Chemical Indicator receive FDA 510(k) clearance?

PMSSteripack Flat Sterilization Pouch (FP) and Roll (FL) with Chemical Indicator received FDA 510(k) clearance on 2017-10-13, under 510(k) number K162362.

Who is the listed applicant for PMSSteripack Flat Sterilization Pouch (FP) and Roll (FL) with Chemical Indicator?

The FDA 510(k) record lists Pms Tibbi Cihazlar Teknolojisi San VE Tic AS as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PMSSteripack Flat Sterilization Pouch (FP) and Roll (FL) with Chemical Indicator?

The FDA product code for PMSSteripack Flat Sterilization Pouch (FP) and Roll (FL) with Chemical Indicator 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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