Cleared Traditional

FCI MESH WRAPPED BIOCERAMIC ORBITAL IMPLANT

K023400 · Fci Ophthalmics, Inc. · Ophthalmic
Aug 2003
Decision
317d
Days
Class 2
Risk

About This 510(k) Submission

K023400 is an FDA 510(k) clearance for the FCI MESH WRAPPED BIOCERAMIC ORBITAL IMPLANT, a Implant, Eye Sphere (Class II — Special Controls, product code HPZ), submitted by Fci Ophthalmics, Inc. (Centercille, US). The FDA issued a Cleared decision on August 22, 2003, 317 days after receiving the submission on October 9, 2002. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.3320.

Submission Details

510(k) Number K023400 FDA.gov
FDA Decision Cleared SESE
Date Received October 09, 2002
Decision Date August 22, 2003
Days to Decision 317 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Statement

Device Classification

Product Code HPZ — Implant, Eye Sphere
Device Class Class II — Special Controls
CFR Regulation 21 CFR 886.3320