Cleared Traditional

COBO TEMPORARY KERATOPROSTHESIS

K895013 · Ocular Instruments, Inc. · Ophthalmic
Oct 1989
Decision
84d
Days
Class 2
Risk

About This 510(k) Submission

K895013 is an FDA 510(k) clearance for the COBO 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 October 31, 1989, 84 days after receiving the submission on August 8, 1989. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.3400.

Submission Details

510(k) Number K895013 FDA.gov
FDA Decision Cleared SESE
Date Received August 08, 1989
Decision Date October 31, 1989
Days to Decision 84 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