FDA 510(k)

SmartMouth DryMouth Oral Rinse

K-Nummer: K181194 · 2019-02-15

AntragstellerTriumph Pharmaceuticals, Inc.

Entscheidungsdatum2019-02-15

ProduktcodeLFD

EntscheidungSubstantially Equivalent

Produktübersicht

SmartMouth DryMouth Oral Rinse is the device name listed in this FDA 510(k) record. The listed applicant is Triumph Pharmaceuticals, Inc.. It received FDA 510(k) clearance on 2019-02-15 under 510(k) number K181194. The device is classified under product code LFD. FDA Decision: Substantially Equivalent.

Häufig gestellte Fragen

What is the SmartMouth DryMouth Oral Rinse?

SmartMouth DryMouth Oral Rinse is a medical device that received FDA 510(k) clearance on 2019-02-15. The listed applicant is Triumph Pharmaceuticals, Inc.. The 510(k) number is K181194.

When did SmartMouth DryMouth Oral Rinse receive FDA 510(k) clearance?

SmartMouth DryMouth Oral Rinse received FDA 510(k) clearance on 2019-02-15, under 510(k) number K181194.

Who is the listed applicant for SmartMouth DryMouth Oral Rinse?

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

What is the FDA product code for SmartMouth DryMouth Oral Rinse?

The FDA product code for SmartMouth DryMouth Oral Rinse is LFD.

Zugehörige klinische Studien

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Verwandte Geräte (Code: LFD)

K253778Allday Moisturizing RinseElevate Oral Care K250390CloSYS® Dry Mouth Sensitive Mouth RinseRowpar Pharmaceuticals, Inc.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

Offizielle Quelle

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