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FDA 510(k)

無菌針筒，配安全針

K 號：K211753 · 2021-10-14

申請人Jiangxi Hongda Medical Equipment Group , Ltd.
決定日期2021-10-14
產品代碼MEG
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

Sterile Syringe With Safety Needle is the device name listed in this FDA 510(k) record. The listed applicant is Jiangxi Hongda Medical Equipment Group , Ltd.. It received FDA 510(k) clearance on 2021-10-14 under 510(k) number K211753. The device is classified under product code MEG. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Sterile Syringe With Safety Needle?

Sterile Syringe With Safety Needle is a medical device that received FDA 510(k) clearance on 2021-10-14. The listed applicant is Jiangxi Hongda Medical Equipment Group , Ltd.. The 510(k) number is K211753.

When did Sterile Syringe With Safety Needle receive FDA 510(k) clearance?

Sterile Syringe With Safety Needle received FDA 510(k) clearance on 2021-10-14, under 510(k) number K211753.

Who is the listed applicant for Sterile Syringe With Safety Needle?

The FDA 510(k) record lists Jiangxi Hongda Medical Equipment Group , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Sterile Syringe With Safety Needle?

The FDA product code for Sterile Syringe With Safety Needle is MEG.

相關臨床試驗

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其他以 Jiangxi Hongda Medical Equipment Group , Ltd. 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。

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相關器械（代碼：MEG）

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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