FDA 510(k)

AllureTM手術マスク

K番号: K212926 · 2022-09-16

決定日2022-09-16

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

AllureTM Surgical Mask is the device name listed in this FDA 510(k) record. The listed applicant is Allure Gift Wraps Private Limited. It received FDA 510(k) clearance on 2022-09-16 under 510(k) number K212926. 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 AllureTM Surgical Mask?

AllureTM Surgical Mask is a medical device that received FDA 510(k) clearance on 2022-09-16. The listed applicant is Allure Gift Wraps Private Limited. The 510(k) number is K212926.

When did AllureTM Surgical Mask receive FDA 510(k) clearance?

AllureTM Surgical Mask received FDA 510(k) clearance on 2022-09-16, under 510(k) number K212926.

Who is the listed applicant for AllureTM Surgical Mask?

The FDA 510(k) record lists Allure Gift Wraps Private Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AllureTM Surgical Mask?

The FDA product code for AllureTM Surgical Mask is FXX.

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AllureTM手術マスク

医療機器の概要

よくある質問

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