FDA 510(k)

NEOCERA Advanced Barrier Cream

Número K: K170911 · 2017-08-22

Data da decisão2017-08-22

Código do produtoFRO

DecisãoSubstantially Equivalent

Resumo do dispositivo

NEOCERA Advanced Barrier Cream is the device name listed in this FDA 510(k) record. The listed applicant is Exeltis USA Dermatology, LLC. It received FDA 510(k) clearance on 2017-08-22 under 510(k) number K170911. The device is classified under product code FRO. Product code FRO falls under the category of Anesthesiology, which includes devices for anesthetic delivery and patient monitoring. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the NEOCERA Advanced Barrier Cream?

NEOCERA Advanced Barrier Cream is a medical device that received FDA 510(k) clearance on 2017-08-22. The listed applicant is Exeltis USA Dermatology, LLC. The 510(k) number is K170911.

When did NEOCERA Advanced Barrier Cream receive FDA 510(k) clearance?

NEOCERA Advanced Barrier Cream received FDA 510(k) clearance on 2017-08-22, under 510(k) number K170911.

Who is the listed applicant for NEOCERA Advanced Barrier Cream?

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

What is the FDA product code for NEOCERA Advanced Barrier Cream?

The FDA product code for NEOCERA Advanced Barrier Cream is FRO. This falls under the Anesthesiology category.

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