FDA 510(k)

Fuselier Intraoral Nighttime Device (FIND)

Número K: K161980 · 2017-02-07

Data da decisão2017-02-07

Código do produtoLRK

Comité consultivoDE

DecisãoSubstantially Equivalent

Resumo do dispositivo

Fuselier Intraoral Nighttime Device (FIND) is the device name listed in this FDA 510(k) record. The listed applicant is Fuselier Enterprises, LLC. It received FDA 510(k) clearance on 2017-02-07 under 510(k) number K161980. 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 Fuselier Intraoral Nighttime Device (FIND)?

Fuselier Intraoral Nighttime Device (FIND) is a medical device that received FDA 510(k) clearance on 2017-02-07. The listed applicant is Fuselier Enterprises, LLC. The 510(k) number is K161980.

When did Fuselier Intraoral Nighttime Device (FIND) receive FDA 510(k) clearance?

Fuselier Intraoral Nighttime Device (FIND) received FDA 510(k) clearance on 2017-02-07, under 510(k) number K161980.

Who is the listed applicant for Fuselier Intraoral Nighttime Device (FIND)?

The FDA 510(k) record lists Fuselier Enterprises, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Fuselier Intraoral Nighttime Device (FIND)?

The FDA product code for Fuselier Intraoral Nighttime Device (FIND) is LRK.

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