Cleared Traditional

LANDERS WIDE FIELD TEMPORARY KERATOPROSTHESIS

K910828 · Ocular Instruments, Inc. · Ophthalmic
Aug 1991
Decision
175d
Days
Class 2
Risk

About This 510(k) Submission

K910828 is an FDA 510(k) clearance for the LANDERS WIDE FIELD TEMPORARY KERATOPROSTHESIS, a Keratoprosthesis, Temporary Implant, Surgical Use (Class II — Special Controls, product code MLP), submitted by Ocular Instruments, Inc. (Bellevue, US). The FDA issued a Cleared decision on August 21, 1991, 175 days after receiving the submission on February 27, 1991. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.3400.

Submission Details

510(k) Number K910828 FDA.gov
FDA Decision Cleared SESE
Date Received February 27, 1991
Decision Date August 21, 1991
Days to Decision 175 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary —

Device Classification

Product Code MLP — Keratoprosthesis, Temporary Implant, Surgical Use
Device Class Class II — Special Controls
CFR Regulation 21 CFR 886.3400