Cleared Traditional

MULTIJECT INJECTOR AND MICROGLIDE CARTRIDGE

K040837 · Medicel AG · Ophthalmic
Jun 2004
Decision
78d
Days
Class 1
Risk

About This 510(k) Submission

K040837 is an FDA 510(k) clearance for the MULTIJECT INJECTOR AND MICROGLIDE CARTRIDGE, a Folders And Injectors, Intraocular Lens (iol) (Class I — General Controls, product code MSS), submitted by Medicel AG (Hasbrouck Heights, US). The FDA issued a Cleared decision on June 17, 2004, 78 days after receiving the submission on March 31, 2004. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4300.

Submission Details

510(k) Number K040837 FDA.gov
FDA Decision Cleared SESE
Date Received March 31, 2004
Decision Date June 17, 2004
Days to Decision 78 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF

Device Classification

Product Code MSS — Folders And Injectors, Intraocular Lens (iol)
Device Class Class I — General Controls
CFR Regulation 21 CFR 886.4300

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