FDA 510(k)

シーケル・タモンプラスティック・アプリケーター付き

K番号: K230419 · 2023-08-03

決定日2023-08-03

製品コードHEB

諮問委員会医薬品機器規制テキストの翻訳は以下の通りです。 [原文] OB [翻訳] OB

決定大幅同等

医療機器の概要

Sequel Tampon with Plastic Applicator is the device name listed in this FDA 510(k) record. The listed applicant is Tampro, Inc.. It received FDA 510(k) clearance on 2023-08-03 under 510(k) number K230419. The device is classified under product code HEB. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the Sequel Tampon with Plastic Applicator?

Sequel Tampon with Plastic Applicator is a medical device that received FDA 510(k) clearance on 2023-08-03. The listed applicant is Tampro, Inc.. The 510(k) number is K230419.

When did Sequel Tampon with Plastic Applicator receive FDA 510(k) clearance?

Sequel Tampon with Plastic Applicator received FDA 510(k) clearance on 2023-08-03, under 510(k) number K230419.

Who is the listed applicant for Sequel Tampon with Plastic Applicator?

The FDA 510(k) record lists Tampro, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Sequel Tampon with Plastic Applicator?

The FDA product code for Sequel Tampon with Plastic Applicator is HEB.

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シーケル・タモンプラスティック・アプリケーター付き

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：HEB）

公式ソース