FDA 510(k)

CloSYS® Dry Mouth Sensitive Mouth Rinse

K-Nummer: K250390 · 2025-05-19

AntragstellerRowpar Pharmaceuticals, Inc.

Entscheidungsdatum2025-05-19

ProduktcodeLFD

EntscheidungSubstantially Equivalent

Produktübersicht

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.

Häufig gestellte Fragen

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.

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Verwandte Geräte (Code: LFD)

K253778Allday Moisturizing RinseElevate 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

Offizielle Quelle

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