FDA 510(k)

Boston One Step Liquid Enzymatic Cleaner

Número K: K200416 · 2020-09-23

Data da decisão2020-09-23

Código do produtoMRC

Comité consultivoOP

DecisãoSubstantially Equivalent

Resumo do dispositivo

Boston One Step Liquid Enzymatic Cleaner is the device name listed in this FDA 510(k) record. The listed applicant is Bausch & Lomb, Incorporated. It received FDA 510(k) clearance on 2020-09-23 under 510(k) number K200416. The device is classified under product code MRC. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Boston One Step Liquid Enzymatic Cleaner?

Boston One Step Liquid Enzymatic Cleaner is a medical device that received FDA 510(k) clearance on 2020-09-23. The listed applicant is Bausch & Lomb, Incorporated. The 510(k) number is K200416.

When did Boston One Step Liquid Enzymatic Cleaner receive FDA 510(k) clearance?

Boston One Step Liquid Enzymatic Cleaner received FDA 510(k) clearance on 2020-09-23, under 510(k) number K200416.

Who is the listed applicant for Boston One Step Liquid Enzymatic Cleaner?

The FDA 510(k) record lists Bausch & Lomb, Incorporated as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Boston One Step Liquid Enzymatic Cleaner?

The FDA product code for Boston One Step Liquid Enzymatic Cleaner is MRC.

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Fonte oficial

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