FDA 510(k)

Unscented Tampon

K番号: K241064 · 2025-01-10

申請者Shandong Intco Hygiene Products Co., Ltd.

決定日2025-01-10

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Substantially Equivalent

医療機器の概要

Unscented Tampon is the device name listed in this FDA 510(k) record. The listed applicant is Shandong Intco Hygiene Products Co., Ltd.. It received FDA 510(k) clearance on 2025-01-10 under 510(k) number K241064. 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 Unscented Tampon?

Unscented Tampon is a medical device that received FDA 510(k) clearance on 2025-01-10. The listed applicant is Shandong Intco Hygiene Products Co., Ltd.. The 510(k) number is K241064.

When did Unscented Tampon receive FDA 510(k) clearance?

Unscented Tampon received FDA 510(k) clearance on 2025-01-10, under 510(k) number K241064.

Who is the listed applicant for Unscented Tampon?

The FDA 510(k) record lists Shandong Intco Hygiene Products Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Unscented Tampon?

The FDA product code for Unscented Tampon is HEB.

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Unscented Tampon

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