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FDA 510(k)

EYE CUP, STERILE 1 AND NON STERILE

K-Number: K051414 · 2005-06-16

ApplicantTollot Pty.Ltd.(Aaxis Pacific)
Decision Date2005-06-16
Product CodeLXQ
DecisionSubstantially Equivalent

Device Summary

EYE CUP, STERILE 1 AND NON STERILE is the device name listed in this FDA 510(k) record. The listed applicant is Tollot Pty.Ltd.(Aaxis Pacific). It received FDA 510(k) clearance on 2005-06-16 under 510(k) number K051414. The device is classified under product code LXQ. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EYE CUP, STERILE 1 AND NON STERILE?

EYE CUP, STERILE 1 AND NON STERILE is a medical device that received FDA 510(k) clearance on 2005-06-16. The listed applicant is Tollot Pty.Ltd.(Aaxis Pacific). The 510(k) number is K051414.

When did EYE CUP, STERILE 1 AND NON STERILE receive FDA 510(k) clearance?

EYE CUP, STERILE 1 AND NON STERILE received FDA 510(k) clearance on 2005-06-16, under 510(k) number K051414.

Who is the listed applicant for EYE CUP, STERILE 1 AND NON STERILE?

The FDA 510(k) record lists Tollot Pty.Ltd.(Aaxis Pacific) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EYE CUP, STERILE 1 AND NON STERILE?

The FDA product code for EYE CUP, STERILE 1 AND NON STERILE is LXQ.

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Related Devices (Code: LXQ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K971134VISTA EYESHOWERJohn BranchK881369ADVANCE DIAGNOSTICS DISPOSABLE EYECUPAdvantage Diagnostics Corp.

Official Source

View on FDA Database →

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

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