Cleared Traditional

RETINAL DETACHMENT IMPLANTS, INCLUDING BANDS, STRIPS (RAILS) AND SPONGES

K980816 · Fci Ophthalmics, Inc. · Ophthalmic
Sep 1998
Decision
199d
Days
Class 2
Risk

About This 510(k) Submission

K980816 is an FDA 510(k) clearance for the RETINAL DETACHMENT IMPLANTS, INCLUDING BANDS, STRIPS (RAILS) AND SPONGES, a Implant, Orbital, Extra-ocular (Class II — Special Controls, product code HQX), submitted by Fci Ophthalmics, Inc. (Marshfield Hills, US). The FDA issued a Cleared decision on September 18, 1998, 199 days after receiving the submission on March 3, 1998. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.3340.

Submission Details

510(k) Number K980816 FDA.gov
FDA Decision Cleared SESE
Date Received March 03, 1998
Decision Date September 18, 1998
Days to Decision 199 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Statement

Device Classification

Product Code HQX — Implant, Orbital, Extra-ocular
Device Class Class II — Special Controls
CFR Regulation 21 CFR 886.3340

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