FDA 510(k)

CloSYS® Dry Mouth Sensitive Mouth Rinse

Номер K: K250390 · 2025-05-19

Дата решения2025-05-19

Код продуктаLFD

РешениеSubstantially Equivalent

Описание устройства

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.

Часто задаваемые вопросы

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.

Связанные клинические исследования

Связанные записи сопоставляются автоматически на основании названий, кодов продукции или иных метаданных. Сопоставление не подтверждает клиническую, научную, корпоративную или регуляторную связь; ознакомьтесь с официальными источниками по ссылкам.

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Связанные устройства (Код: LFD)

K253778Allday Увлажняющий ПолоскательElevate Oral Care K240508Salivea Dry Mouth Moisturizing Gel (Dry Mouth Moisturizing Gel)Laclede, Inc.K234015Caphosol® Artifical Saliva (32 doses sachet box)Eusa Pharma (Uk) Limited K231205GuruNanda Dry Mouth Oral Rinse and GuruNanda Dry Mouth Oral SprayGurunanda, LLC K202689Dentilube SprayOxy2plus, LLC K203567Oral-B Dry Mouth Oral RinseThe Procter & Gamble Company

Официальный источник

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