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FDA 510(k)

紙質消毒袋及卷材(消毒袋平面,消毒袋有邊,消毒卷材平面,消毒卷材有邊)

K 號:K182184 · 2019-10-10

決定日期2019-10-10
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

Paper Sterilization Pouch and Roll(Sterilization Pouch Flat, Sterilization Pouch Gusseted, Sterilization Roll Flat and Sterilization Roll Gusseted) is the device name listed in this FDA 510(k) record. The listed applicant is Mdk (Shanghai) Medical Packing Co., Ltd.. It received FDA 510(k) clearance on 2019-10-10 under 510(k) number K182184. 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 Paper Sterilization Pouch and Roll(Sterilization Pouch Flat, Sterilization Pouch Gusseted, Sterilization Roll Flat and Sterilization Roll Gusseted)?

Paper Sterilization Pouch and Roll(Sterilization Pouch Flat, Sterilization Pouch Gusseted, Sterilization Roll Flat and Sterilization Roll Gusseted) is a medical device that received FDA 510(k) clearance on 2019-10-10. The listed applicant is Mdk (Shanghai) Medical Packing Co., Ltd.. The 510(k) number is K182184.

When did Paper Sterilization Pouch and Roll(Sterilization Pouch Flat, Sterilization Pouch Gusseted, Sterilization Roll Flat and Sterilization Roll Gusseted) receive FDA 510(k) clearance?

Paper Sterilization Pouch and Roll(Sterilization Pouch Flat, Sterilization Pouch Gusseted, Sterilization Roll Flat and Sterilization Roll Gusseted) received FDA 510(k) clearance on 2019-10-10, under 510(k) number K182184.

Who is the listed applicant for Paper Sterilization Pouch and Roll(Sterilization Pouch Flat, Sterilization Pouch Gusseted, Sterilization Roll Flat and Sterilization Roll Gusseted)?

The FDA 510(k) record lists Mdk (Shanghai) Medical Packing Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Paper Sterilization Pouch and Roll(Sterilization Pouch Flat, Sterilization Pouch Gusseted, Sterilization Roll Flat and Sterilization Roll Gusseted)?

The FDA product code for Paper Sterilization Pouch and Roll(Sterilization Pouch Flat, Sterilization Pouch Gusseted, Sterilization Roll Flat and Sterilization Roll Gusseted) 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。

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。

官方來源

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