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FDA 510(k)

TheraBreath Dry Mouth Oral Rinse, TheraBreath Dry Mouth Lozenges

N.º K: K171542 · 2018-03-16

SolicitanteDr. Harold Katz, LLC (Dba Therabreath
Fecha de decisión2018-03-16
Código de productoLFD
DecisiónSubstantially Equivalent

Resumen del dispositivo

TheraBreath Dry Mouth Oral Rinse, TheraBreath Dry Mouth Lozenges is the device name listed in this FDA 510(k) record. The listed applicant is Dr. Harold Katz, LLC (Dba Therabreath. It received FDA 510(k) clearance on 2018-03-16 under 510(k) number K171542. The device is classified under product code LFD. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the TheraBreath Dry Mouth Oral Rinse, TheraBreath Dry Mouth Lozenges?

TheraBreath Dry Mouth Oral Rinse, TheraBreath Dry Mouth Lozenges is a medical device that received FDA 510(k) clearance on 2018-03-16. The listed applicant is Dr. Harold Katz, LLC (Dba Therabreath. The 510(k) number is K171542.

When did TheraBreath Dry Mouth Oral Rinse, TheraBreath Dry Mouth Lozenges receive FDA 510(k) clearance?

TheraBreath Dry Mouth Oral Rinse, TheraBreath Dry Mouth Lozenges received FDA 510(k) clearance on 2018-03-16, under 510(k) number K171542.

Who is the listed applicant for TheraBreath Dry Mouth Oral Rinse, TheraBreath Dry Mouth Lozenges?

The FDA 510(k) record lists Dr. Harold Katz, LLC (Dba Therabreath as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TheraBreath Dry Mouth Oral Rinse, TheraBreath Dry Mouth Lozenges?

The FDA product code for TheraBreath Dry Mouth Oral Rinse, TheraBreath Dry Mouth Lozenges is LFD.

Ensayos clínicos relacionados

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Dispositivos relacionados (Código: LFD)

Los registros relacionados se emparejan automáticamente mediante nombres, códigos de producto u otros metadatos. Un emparejamiento no establece una relación clínica, científica, corporativa o regulatoria verificada; revise las fuentes oficiales enlazadas.

K253778Enjuague Hidratante AlldayElevate Oral CareK250390CloSYS® 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) LimitedK231205GuruNanda Dry Mouth Oral Rinse and GuruNanda Dry Mouth Oral SprayGurunanda, LLCK202689Dentilube SprayOxy2plus, LLC

Fuente oficial

Ver en la base de datos de la FDA →

Datos procedentes de la API abierta de la FDA. Para obtener la información más actualizada y autoritativa, consulte siempre el registro oficial.

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