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FDA 510(k)

單次使用无菌皮下注射針筒，含/不含針頭，單次使用无菌皮下注射針

K 號：K212846 · 2022-08-30

申請人Jiangsu Jichun Medical Devices Co., Ltd.
決定日期2022-08-30
產品代碼FMF
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 Hypodermic Syringe for Single Use, with/without Needle, Sterile Hypodermic Needle for Single Use is the device name listed in this FDA 510(k) record. The listed applicant is Jiangsu Jichun Medical Devices Co., Ltd.. It received FDA 510(k) clearance on 2022-08-30 under 510(k) number K212846. The device is classified under product code FMF. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Sterile Hypodermic Syringe for Single Use, with/without Needle, Sterile Hypodermic Needle for Single Use?

Sterile Hypodermic Syringe for Single Use, with/without Needle, Sterile Hypodermic Needle for Single Use is a medical device that received FDA 510(k) clearance on 2022-08-30. The listed applicant is Jiangsu Jichun Medical Devices Co., Ltd.. The 510(k) number is K212846.

When did Sterile Hypodermic Syringe for Single Use, with/without Needle, Sterile Hypodermic Needle for Single Use receive FDA 510(k) clearance?

Sterile Hypodermic Syringe for Single Use, with/without Needle, Sterile Hypodermic Needle for Single Use received FDA 510(k) clearance on 2022-08-30, under 510(k) number K212846.

Who is the listed applicant for Sterile Hypodermic Syringe for Single Use, with/without Needle, Sterile Hypodermic Needle for Single Use?

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

What is the FDA product code for Sterile Hypodermic Syringe for Single Use, with/without Needle, Sterile Hypodermic Needle for Single Use?

The FDA product code for Sterile Hypodermic Syringe for Single Use, with/without Needle, Sterile Hypodermic Needle for Single Use is FMF.

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相關器械（代碼：FMF）

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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