FDA 510(k)

IRRIGATION ASPIRATION KIT

K-Number: K833405 · 1984-01-06

Decision Date1984-01-06

Product CodeHQC

Advisory CommitteeOP

DecisionSubstantially Equivalent

Device Summary

IRRIGATION ASPIRATION KIT is the device name listed in this FDA 510(k) record. The listed applicant is American Medical Optics. It received FDA 510(k) clearance on 1984-01-06 under 510(k) number K833405. 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 IRRIGATION ASPIRATION KIT?

IRRIGATION ASPIRATION KIT is a medical device that received FDA 510(k) clearance on 1984-01-06. The listed applicant is American Medical Optics. The 510(k) number is K833405.

When did IRRIGATION ASPIRATION KIT receive FDA 510(k) clearance?

IRRIGATION ASPIRATION KIT received FDA 510(k) clearance on 1984-01-06, under 510(k) number K833405.

Who is the listed applicant for IRRIGATION ASPIRATION KIT?

The FDA 510(k) record lists American Medical Optics as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for IRRIGATION ASPIRATION KIT?

The FDA product code for IRRIGATION ASPIRATION KIT is HQC.

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Other records listing American Medical Optics as applicant

K860001BARRAQUER-KRUMEICH REFRACTIVE SET K851263AMER. MEDICAL OPTIC MONOCULAR DIRECT OPHTHALMASCOP K851264AMER. MEDICAL OPTICS MONOCULAR INDIRECT OPHTHALMAS K851262AMER. MEDICAL OPTICAL BINOCULAR INDIRECT OPHTHALMA K844150MEDICAL OPTICS PHACOEMULSIFICATION KIT K843966ARGON/KRYPTON LASER PHOTOCOAGULATOR SYS

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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.