FDA 510(k)

GOLFF Sterile Anti-Fog Solution

Número K: K231822 · 2024-02-26

RequerenteBatrik Medical Manufacturing, Inc.

Data da decisão2024-02-26

Código do produtoOCT

Comité consultivoGU

DecisãoSubstantially Equivalent

Resumo do dispositivo

GOLFF Sterile Anti-Fog Solution is the device name listed in this FDA 510(k) record. The listed applicant is Batrik Medical Manufacturing, Inc.. It received FDA 510(k) clearance on 2024-02-26 under 510(k) number K231822. The device is classified under product code OCT. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the GOLFF Sterile Anti-Fog Solution?

GOLFF Sterile Anti-Fog Solution is a medical device that received FDA 510(k) clearance on 2024-02-26. The listed applicant is Batrik Medical Manufacturing, Inc.. The 510(k) number is K231822.

When did GOLFF Sterile Anti-Fog Solution receive FDA 510(k) clearance?

GOLFF Sterile Anti-Fog Solution received FDA 510(k) clearance on 2024-02-26, under 510(k) number K231822.

Who is the listed applicant for GOLFF Sterile Anti-Fog Solution?

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

What is the FDA product code for GOLFF Sterile Anti-Fog Solution?

The FDA product code for GOLFF Sterile Anti-Fog Solution is OCT.

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Fonte oficial

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