FDA 510(k)

DEFEND Ear-loop Face Masks

Número K: K201127 · 2021-04-14

RequerenteYoung Dental Manufacturing Co. 1, LLC

Data da decisão2021-04-14

Código do produtoFXX

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

DEFEND Ear-loop Face Masks is the device name listed in this FDA 510(k) record. The listed applicant is Young Dental Manufacturing Co. 1, LLC. It received FDA 510(k) clearance on 2021-04-14 under 510(k) number K201127. The device is classified under product code FXX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the DEFEND Ear-loop Face Masks?

DEFEND Ear-loop Face Masks is a medical device that received FDA 510(k) clearance on 2021-04-14. The listed applicant is Young Dental Manufacturing Co. 1, LLC. The 510(k) number is K201127.

When did DEFEND Ear-loop Face Masks receive FDA 510(k) clearance?

DEFEND Ear-loop Face Masks received FDA 510(k) clearance on 2021-04-14, under 510(k) number K201127.

Who is the listed applicant for DEFEND Ear-loop Face Masks?

The FDA 510(k) record lists Young Dental Manufacturing Co. 1, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DEFEND Ear-loop Face Masks?

The FDA product code for DEFEND Ear-loop Face Masks is FXX.

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