FDA 510(k)

単回使用用無菌皮下注射針

K番号: K180259 · 2018-05-18

申請者Jiangsu Shenli Medical Production Co., Ltd.

決定日2018-05-18

製品コードFMI

諮問委員会医療機器規制テキストの翻訳は以下の通りです。 HO [翻訳が提供されなかったため、原文の「HO」がそのまま使用されます]

決定大幅同等

医療機器の概要

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.

よくある質問

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.

申請者としてJiangsu Shenli Medical Production Co., Ltd.を記載するその他の記録

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