FDA 510(k)

医療外科マスク-非無菌

K番号: K202594 · 2021-01-06

決定日2021-01-06

製品コードFXX

諮問委員会SU （以下のテキストは翻訳されていません。） Policy: medical-regulatory-v1

決定大幅同等

医療機器の概要

Medical Surgical Masks-Non Sterile is the device name listed in this FDA 510(k) record. The listed applicant is Shandong T&F Nonwoven Co., Ltd.. It received FDA 510(k) clearance on 2021-01-06 under 510(k) number K202594. The device is classified under product code FXX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the Medical Surgical Masks-Non Sterile?

Medical Surgical Masks-Non Sterile is a medical device that received FDA 510(k) clearance on 2021-01-06. The listed applicant is Shandong T&F Nonwoven Co., Ltd.. The 510(k) number is K202594.

When did Medical Surgical Masks-Non Sterile receive FDA 510(k) clearance?

Medical Surgical Masks-Non Sterile received FDA 510(k) clearance on 2021-01-06, under 510(k) number K202594.

Who is the listed applicant for Medical Surgical Masks-Non Sterile?

The FDA 510(k) record lists Shandong T&F Nonwoven Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Medical Surgical Masks-Non Sterile?

The FDA product code for Medical Surgical Masks-Non Sterile is FXX.

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医療外科マスク-非無菌

医療機器の概要

よくある質問

関連する臨床試験

関連機器（コード：FXX）

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