FDA 510(k)

無菌美学カニューレおよび皮下注射針

K番号: K223327 · 2023-02-16

申請者Shanghai Kindly Enterprise Development Group Co., Ltd.

決定日2023-02-16

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 Aesthetic Cannula and Hypodermic Needle is the device name listed in this FDA 510(k) record. The listed applicant is Shanghai Kindly Enterprise Development Group Co., Ltd.. It received FDA 510(k) clearance on 2023-02-16 under 510(k) number K223327. 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 Aesthetic Cannula and Hypodermic Needle?

Sterile Aesthetic Cannula and Hypodermic Needle is a medical device that received FDA 510(k) clearance on 2023-02-16. The listed applicant is Shanghai Kindly Enterprise Development Group Co., Ltd.. The 510(k) number is K223327.

When did Sterile Aesthetic Cannula and Hypodermic Needle receive FDA 510(k) clearance?

Sterile Aesthetic Cannula and Hypodermic Needle received FDA 510(k) clearance on 2023-02-16, under 510(k) number K223327.

Who is the listed applicant for Sterile Aesthetic Cannula and Hypodermic Needle?

The FDA 510(k) record lists Shanghai Kindly Enterprise Development Group Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Sterile Aesthetic Cannula and Hypodermic Needle?

The FDA product code for Sterile Aesthetic Cannula and Hypodermic Needle is FMI.

申請者としてShanghai Kindly Enterprise Development Group Co., Ltd.を記載するその他の記録

K223678単回使用用無菌注射器

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