FDA 510(k)

Lollipop BiteBlock

Número K: K200652 · 2020-07-06

Data da decisão2020-07-06

Código do produtoIYE

Comité consultivoRA

DecisãoSubstantially Equivalent

Resumo do dispositivo

Lollipop BiteBlock is the device name listed in this FDA 510(k) record. The listed applicant is Radtec Medical Devices, Inc.. It received FDA 510(k) clearance on 2020-07-06 under 510(k) number K200652. The device is classified under product code IYE. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Lollipop BiteBlock?

Lollipop BiteBlock is a medical device that received FDA 510(k) clearance on 2020-07-06. The listed applicant is Radtec Medical Devices, Inc.. The 510(k) number is K200652.

When did Lollipop BiteBlock receive FDA 510(k) clearance?

Lollipop BiteBlock received FDA 510(k) clearance on 2020-07-06, under 510(k) number K200652.

Who is the listed applicant for Lollipop BiteBlock?

The FDA 510(k) record lists Radtec Medical Devices, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Lollipop BiteBlock?

The FDA product code for Lollipop BiteBlock is IYE.

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