FDA 510(k)

消毒袋/卷材，採用泰维克材料製成

K 號：K180672 · 2018-06-06

決定日期2018-06-06

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 Pouch/Roll Made with Tyvek is the device name listed in this FDA 510(k) record. The listed applicant is Sigma Medical Supplies Corporation. It received FDA 510(k) clearance on 2018-06-06 under 510(k) number K180672. 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 Pouch/Roll Made with Tyvek?

Sterilization Pouch/Roll Made with Tyvek is a medical device that received FDA 510(k) clearance on 2018-06-06. The listed applicant is Sigma Medical Supplies Corporation. The 510(k) number is K180672.

When did Sterilization Pouch/Roll Made with Tyvek receive FDA 510(k) clearance?

Sterilization Pouch/Roll Made with Tyvek received FDA 510(k) clearance on 2018-06-06, under 510(k) number K180672.

Who is the listed applicant for Sterilization Pouch/Roll Made with Tyvek?

The FDA 510(k) record lists Sigma Medical Supplies Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Sterilization Pouch/Roll Made with Tyvek?

The FDA product code for Sterilization Pouch/Roll Made with Tyvek is FRG.

其他以 Sigma Medical Supplies Corporation 為申請人之記錄

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K202462SIGMA 過濾包及捲材

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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