FDA 510(k)

單次使用无菌皮下針頭

K 號：K180259 · 2018-05-18

申請人Jiangsu Shenli Medical Production Co., Ltd.

決定日期2018-05-18

產品代碼FMI

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 Needle for Single Use is the device name listed in this FDA 510(k) record. The listed applicant is Jiangsu Shenli Medical Production Co., Ltd.. It received FDA 510(k) clearance on 2018-05-18 under 510(k) number K180259. The device is classified under product code FMI. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Sterile Hypodermic Needle for Single Use?

Sterile Hypodermic Needle for Single Use is a medical device that received FDA 510(k) clearance on 2018-05-18. The listed applicant is Jiangsu Shenli Medical Production Co., Ltd.. The 510(k) number is K180259.

When did Sterile Hypodermic Needle for Single Use receive FDA 510(k) clearance?

Sterile Hypodermic Needle for Single Use received FDA 510(k) clearance on 2018-05-18, under 510(k) number K180259.

Who is the listed applicant for Sterile Hypodermic Needle for Single Use?

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

What is the FDA product code for Sterile Hypodermic Needle for Single Use?

The FDA product code for Sterile Hypodermic Needle for Single Use is FMI.

其他以 Jiangsu Shenli Medical Production Co., Ltd. 為申請人之記錄

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