FDA 510(k)

TheraBreath Dry Mouth Oral Rinse, TheraBreath Dry Mouth Lozenges

Número K: K171542 · 2018-03-16

RequerenteDr. Harold Katz, LLC (Dba Therabreath

Data da decisão2018-03-16

Código do produtoLFD

DecisãoSubstantially Equivalent

Resumo do 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.

Perguntas frequentes

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.

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Fonte oficial

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