醫療設備包裝標籤
K 號：K221016 · 2022-05-05
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申請人Wipak OY
決定日期2022-05-05
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
Steriking Packaging for Medical Devices is the device name listed in this FDA 510(k) record. The listed applicant is Wipak OY. It received FDA 510(k) clearance on 2022-05-05 under 510(k) number K221016. 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 Steriking Packaging for Medical Devices?
Steriking Packaging for Medical Devices is a medical device that received FDA 510(k) clearance on 2022-05-05. The listed applicant is Wipak OY. The 510(k) number is K221016.
When did Steriking Packaging for Medical Devices receive FDA 510(k) clearance?
Steriking Packaging for Medical Devices received FDA 510(k) clearance on 2022-05-05, under 510(k) number K221016.
Who is the listed applicant for Steriking Packaging for Medical Devices?
The FDA 510(k) record lists Wipak OY as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Steriking Packaging for Medical Devices?
The FDA product code for Steriking Packaging for Medical Devices is FRG.
相關臨床試驗
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其他以 Wipak OY 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。
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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