FDA 510(k)

CloSYS®乾燥口内感度口腔洗口液

K番号: K250390 · 2025-05-19

決定日2025-05-19

製品コードLFD

決定Substantially Equivalent

医療機器の概要

CloSYS® Dry Mouth Sensitive Mouth Rinse is the device name listed in this FDA 510(k) record. The listed applicant is Rowpar Pharmaceuticals, Inc.. It received FDA 510(k) clearance on 2025-05-19 under 510(k) number K250390. The device is classified under product code LFD. FDA Decision: Substantially Equivalent.

よくある質問

What is the CloSYS® Dry Mouth Sensitive Mouth Rinse?

CloSYS® Dry Mouth Sensitive Mouth Rinse is a medical device that received FDA 510(k) clearance on 2025-05-19. The listed applicant is Rowpar Pharmaceuticals, Inc.. The 510(k) number is K250390.

When did CloSYS® Dry Mouth Sensitive Mouth Rinse receive FDA 510(k) clearance?

CloSYS® Dry Mouth Sensitive Mouth Rinse received FDA 510(k) clearance on 2025-05-19, under 510(k) number K250390.

Who is the listed applicant for CloSYS® Dry Mouth Sensitive Mouth Rinse?

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

What is the FDA product code for CloSYS® Dry Mouth Sensitive Mouth Rinse?

The FDA product code for CloSYS® Dry Mouth Sensitive Mouth Rinse is LFD.

公式ソース

FDAデータベースで見る →

データはFDA Open APIから取得しています。最新かつ権威ある情報については、常に公式レコードを参照してください。

CloSYS®乾燥口内感度口腔洗口液

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：LFD）

公式ソース