Cleared Traditional

LANDERS HIGH REFRACTIVE INDEX VITRECTOMY LENS SET

K914117 · Ocular Instruments, Inc. · Ophthalmic
Nov 1991
Decision
61d
Days
Class 2
Risk

About This 510(k) Submission

K914117 is an FDA 510(k) clearance for the LANDERS HIGH REFRACTIVE INDEX VITRECTOMY LENS SET, a Lens, Contact, Polymethylmethacrylate, Diagnostic (Class II — Special Controls, product code HJK), submitted by Ocular Instruments, Inc. (Bellevue, US). The FDA issued a Cleared decision on November 13, 1991, 61 days after receiving the submission on September 13, 1991. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.1385.

Submission Details

510(k) Number K914117 FDA.gov
FDA Decision Cleared SESE
Date Received September 13, 1991
Decision Date November 13, 1991
Days to Decision 61 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Statement

Device Classification

Product Code HJK — Lens, Contact, Polymethylmethacrylate, Diagnostic
Device Class Class II — Special Controls
CFR Regulation 21 CFR 886.1385

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