FDA 510(k)

ENFLU 18 (enflufocon A) Daily Wear Contact Lens

Número K: K171575 · 2017-10-24

Data da decisão2017-10-24

Código do produtoHQD

Comité consultivoOP

DecisãoSubstantially Equivalent

Resumo do dispositivo

ENFLU 18 (enflufocon A) Daily Wear Contact Lens is the device name listed in this FDA 510(k) record. The listed applicant is Contamac, Ltd.. It received FDA 510(k) clearance on 2017-10-24 under 510(k) number K171575. The device is classified under product code HQD. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the ENFLU 18 (enflufocon A) Daily Wear Contact Lens?

ENFLU 18 (enflufocon A) Daily Wear Contact Lens is a medical device that received FDA 510(k) clearance on 2017-10-24. The listed applicant is Contamac, Ltd.. The 510(k) number is K171575.

When did ENFLU 18 (enflufocon A) Daily Wear Contact Lens receive FDA 510(k) clearance?

ENFLU 18 (enflufocon A) Daily Wear Contact Lens received FDA 510(k) clearance on 2017-10-24, under 510(k) number K171575.

Who is the listed applicant for ENFLU 18 (enflufocon A) Daily Wear Contact Lens?

The FDA 510(k) record lists Contamac, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ENFLU 18 (enflufocon A) Daily Wear Contact Lens?

The FDA product code for ENFLU 18 (enflufocon A) Daily Wear Contact Lens is HQD.

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Fonte oficial

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