Cleared Traditional

LANDERS 3 STRUT IRRIGATING VITRECTOMY LENS RING

K912253 · Ocular Instruments, Inc. · Ophthalmic
Aug 1991
Decision
78d
Days
Class 2
Risk

About This 510(k) Submission

K912253 is an FDA 510(k) clearance for the LANDERS 3 STRUT IRRIGATING VITRECTOMY LENS RING, a Instrument, Vitreous Aspiration And Cutting, Ac-powered (Class II — Special Controls, product code HQE), submitted by Ocular Instruments, Inc. (Bellevue, US). The FDA issued a Cleared decision on August 7, 1991, 78 days after receiving the submission on May 21, 1991. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4150.

Submission Details

510(k) Number K912253 FDA.gov
FDA Decision Cleared SESE
Date Received May 21, 1991
Decision Date August 07, 1991
Days to Decision 78 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Statement

Device Classification

Product Code HQE — Instrument, Vitreous Aspiration And Cutting, Ac-powered
Device Class Class II — Special Controls
CFR Regulation 21 CFR 886.4150

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