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FDA 510(k)

Phacoemulsification Needle (Tip) and Irrigation Sleeve

Número K: K192418 · 2020-05-27

RequerenteRaico, LLC
Data da decisão2020-05-27
Código do produtoHQC
Comité consultivoOP
DecisãoSubstantially Equivalent

Resumo do dispositivo

Phacoemulsification Needle (Tip) and Irrigation Sleeve is the device name listed in this FDA 510(k) record. The listed applicant is Raico, LLC. It received FDA 510(k) clearance on 2020-05-27 under 510(k) number K192418. The device is classified under product code HQC. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Phacoemulsification Needle (Tip) and Irrigation Sleeve?

Phacoemulsification Needle (Tip) and Irrigation Sleeve is a medical device that received FDA 510(k) clearance on 2020-05-27. The listed applicant is Raico, LLC. The 510(k) number is K192418.

When did Phacoemulsification Needle (Tip) and Irrigation Sleeve receive FDA 510(k) clearance?

Phacoemulsification Needle (Tip) and Irrigation Sleeve received FDA 510(k) clearance on 2020-05-27, under 510(k) number K192418.

Who is the listed applicant for Phacoemulsification Needle (Tip) and Irrigation Sleeve?

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

What is the FDA product code for Phacoemulsification Needle (Tip) and Irrigation Sleeve?

The FDA product code for Phacoemulsification Needle (Tip) and Irrigation Sleeve is HQC.

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