Cleared Traditional

COLLAGEN SHIELD, VARIOUS MODELS

K905825 · Chiron Ophthalmics · Ophthalmic
Jun 1991
Decision
161d
Days
Class 1
Risk

About This 510(k) Submission

K905825 is an FDA 510(k) clearance for the COLLAGEN SHIELD, VARIOUS MODELS, a Collagen Corneal Shield (Class I — General Controls, product code MOE), submitted by Chiron Ophthalmics (Irvine, US). The FDA issued a Cleared decision on June 10, 1991, 161 days after receiving the submission on December 31, 1990. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4750.

Submission Details

510(k) Number K905825 FDA.gov
FDA Decision Cleared SESE
Date Received December 31, 1990
Decision Date June 10, 1991
Days to Decision 161 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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