Cleared Traditional

K874591 - ILLUMINATING INFUSION CONTACT LENS FOR EYE SURGERY
(FDA 510(k) Clearance)

May 1988
Decision
176d
Days
Risk

K874591 is an FDA 510(k) clearance for the ILLUMINATING INFUSION CONTACT LENS FOR EYE SURGERY. This device is classified as a Lens, Contact (polymethylmethacrylate).

Submitted by Vitreo Dynamics, Co. (Southaven, US). The FDA issued a Cleared decision on May 3, 1988, 176 days after receiving the submission on November 9, 1987.

This device falls under the Ophthalmic FDA review panel.

Submission Details

510(k) Number K874591 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 09, 1987
Decision Date May 03, 1988
Days to Decision 176 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary

Device Classification

Product Code HPX — Lens, Contact (polymethylmethacrylate)
Device Class

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