FDA 510(k)

SleepTight Mouthpiece STZ

Número K: K191618 · 2019-12-11

Data da decisão2019-12-11

Código do produtoLRK

Comité consultivoDE

DecisãoSubstantially Equivalent

Resumo do dispositivo

SleepTight Mouthpiece STZ is the device name listed in this FDA 510(k) record. The listed applicant is Michael D Williams Dds PA. It received FDA 510(k) clearance on 2019-12-11 under 510(k) number K191618. The device is classified under product code LRK. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the SleepTight Mouthpiece STZ?

SleepTight Mouthpiece STZ is a medical device that received FDA 510(k) clearance on 2019-12-11. The listed applicant is Michael D Williams Dds PA. The 510(k) number is K191618.

When did SleepTight Mouthpiece STZ receive FDA 510(k) clearance?

SleepTight Mouthpiece STZ received FDA 510(k) clearance on 2019-12-11, under 510(k) number K191618.

Who is the listed applicant for SleepTight Mouthpiece STZ?

The FDA 510(k) record lists Michael D Williams Dds PA as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SleepTight Mouthpiece STZ?

The FDA product code for SleepTight Mouthpiece STZ is LRK.

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Fonte oficial

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