Cleared Traditional

ECKHARDT TEMPORARY KERATOPROSTHESIS

K902491 · Dutch Ophthalmic USA, Inc. · Ophthalmic
Jun 1990
Decision
21d
Days
Class 2
Risk

About This 510(k) Submission

K902491 is an FDA 510(k) clearance for the ECKHARDT TEMPORARY KERATOPROSTHESIS, a Keratoprosthesis, Temporary Implant, Surgical Use (Class II — Special Controls, product code MLP), submitted by Dutch Ophthalmic USA, Inc. (Kingston, US). The FDA issued a Cleared decision on June 26, 1990, 21 days after receiving the submission on June 5, 1990. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.3400.

Submission Details

510(k) Number K902491 FDA.gov
FDA Decision Cleared SESE
Date Received June 05, 1990
Decision Date June 26, 1990
Days to Decision 21 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