Cleared Traditional

RETINAL DETACHMENT IMPLANTS; INCLUDING BANS, STRIPS, TIRES, SLEEVES, CORDS AND SPONGES

K963219 · Fci Ophthalmics, Inc. · Ophthalmic
Oct 1996
Decision
73d
Days
Class 2
Risk

About This 510(k) Submission

K963219 is an FDA 510(k) clearance for the RETINAL DETACHMENT IMPLANTS; INCLUDING BANS, STRIPS, TIRES, SLEEVES, CORDS 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 October 28, 1996, 73 days after receiving the submission on August 16, 1996. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.3340.

Submission Details

510(k) Number K963219 FDA.gov
FDA Decision Cleared SESE
Date Received August 16, 1996
Decision Date October 28, 1996
Days to Decision 73 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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