Cleared Traditional

MEDILENS(TM) CORNEAL SHIELD

K901880 · Chiron Ophthalmics · Ophthalmic
Jul 1990
Decision
67d
Days
Class 1
Risk

About This 510(k) Submission

K901880 is an FDA 510(k) clearance for the MEDILENS(TM) CORNEAL SHIELD, a Collagen Corneal Shield (Class I — General Controls, product code MOE), submitted by Chiron Ophthalmics (Irvine, US). The FDA issued a Cleared decision on July 2, 1990, 67 days after receiving the submission on April 26, 1990. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4750.

Submission Details

510(k) Number K901880 FDA.gov
FDA Decision Cleared SESE
Date Received April 26, 1990
Decision Date July 02, 1990
Days to Decision 67 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary —

Device Classification

Product Code MOE — Collagen Corneal Shield
Device Class Class I — General Controls
CFR Regulation 21 CFR 886.4750

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