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FDA 510(k)

Phacoemulsification Needle (Tip) and Irrigation Sleeve

K-Number: K192418 · 2020-05-27

ApplicantRaico, LLC
Decision Date2020-05-27
Product CodeHQC
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

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.

Frequently Asked Questions

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.

Related Devices (Code: HQC)

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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