FDA 510(k)

単回使用の無菌皮下注射針

K番号: K212207 · 2023-03-23

申請者Shandong Weigao Group Medical Polymer Co., Ltd.

決定日2023-03-23

製品コードFMF

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 Syringe for Single Use is the device name listed in this FDA 510(k) record. The listed applicant is Shandong Weigao Group Medical Polymer Co., Ltd.. It received FDA 510(k) clearance on 2023-03-23 under 510(k) number K212207. The device is classified under product code FMF. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the Sterile Hypodermic Syringe for Single Use?

Sterile Hypodermic Syringe for Single Use is a medical device that received FDA 510(k) clearance on 2023-03-23. The listed applicant is Shandong Weigao Group Medical Polymer Co., Ltd.. The 510(k) number is K212207.

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

Sterile Hypodermic Syringe for Single Use received FDA 510(k) clearance on 2023-03-23, under 510(k) number K212207.

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

The FDA 510(k) record lists Shandong Weigao Group Medical Polymer 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?

The FDA product code for Sterile Hypodermic Syringe for Single Use is FMF.

申請者としてShandong Weigao Group Medical Polymer Co., Ltd.を記載するその他の記録

K212920無菌安全性注射針シリンジ、単回使用用无菌安全性皮下注射針、単回使用用无菌自動無効化シリンジおよび針

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