FDA 510(k)

Reliance獨立消毒包材，Reliance雙連消毒包材

K 號：K171533 · 2017-06-29

決定日期2017-06-29

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

Reliance Solo Sterilization Wrap, Reliance Tandem Sterilization Wrap is the device name listed in this FDA 510(k) record. The listed applicant is Ahlstrom Nonwovens, LLC. It received FDA 510(k) clearance on 2017-06-29 under 510(k) number K171533. 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 Reliance Solo Sterilization Wrap, Reliance Tandem Sterilization Wrap?

Reliance Solo Sterilization Wrap, Reliance Tandem Sterilization Wrap is a medical device that received FDA 510(k) clearance on 2017-06-29. The listed applicant is Ahlstrom Nonwovens, LLC. The 510(k) number is K171533.

When did Reliance Solo Sterilization Wrap, Reliance Tandem Sterilization Wrap receive FDA 510(k) clearance?

Reliance Solo Sterilization Wrap, Reliance Tandem Sterilization Wrap received FDA 510(k) clearance on 2017-06-29, under 510(k) number K171533.

Who is the listed applicant for Reliance Solo Sterilization Wrap, Reliance Tandem Sterilization Wrap?

The FDA 510(k) record lists Ahlstrom Nonwovens, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Reliance Solo Sterilization Wrap, Reliance Tandem Sterilization Wrap?

The FDA product code for Reliance Solo Sterilization Wrap, Reliance Tandem Sterilization Wrap is FRG.

其他以 Ahlstrom Nonwovens, LLC 為申請人之記錄

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。

K160755Reliance獨立消毒包材，Reliance雙連消毒包材

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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