Cleared Traditional

LANDERS-FOULKS TEMP. KERATOPROSTHESIS

K842856 · Ocular Instruments, Inc. · Ophthalmic
Dec 1984
Decision
151d
Days
Class 2
Risk

About This 510(k) Submission

K842856 is an FDA 510(k) clearance for the LANDERS-FOULKS TEMP. 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 December 18, 1984, 151 days after receiving the submission on July 20, 1984. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.3400.

Submission Details

510(k) Number K842856 FDA.gov
FDA Decision Cleared SESE
Date Received July 20, 1984
Decision Date December 18, 1984
Days to Decision 151 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