Cleared Traditional

K073293 - DURETTE IMPLANT
(FDA 510(k) Clearance)

K073293 · Oculo Plastik, Inc. · Ophthalmic
Mar 2008
Decision
117d
Days
Class 2
Risk

K073293 is an FDA 510(k) clearance for the DURETTE IMPLANT, a Implant, Eye Sphere (Class II — Special Controls, product code HPZ), submitted by Oculo Plastik, Inc. (Montreal, Quebec, CA). The FDA issued a Cleared decision on March 19, 2008, 117 days after receiving the submission on November 23, 2007. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.3320.

Submission Details

510(k) Number K073293 FDA.gov
FDA Decision Cleared SESE
Date Received November 23, 2007
Decision Date March 19, 2008
Days to Decision 117 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF

Device Classification

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