Cleared Abbreviated

MENICON PROGENT PROTEIN REMOVER FOR RIGID GAS PERMEABLE CONTACT LENS

K122273 · Menicon Co, Ltd. · Ophthalmic
Jan 2013
Decision
156d
Days
Class 2
Risk

About This 510(k) Submission

K122273 is an FDA 510(k) clearance for the MENICON PROGENT PROTEIN REMOVER FOR RIGID GAS PERMEABLE CONTACT LENS, a Products, Contact Lens Care, Rigid Gas Permeable (Class II — Special Controls, product code MRC), submitted by Menicon Co, Ltd. (Wilmington, US). The FDA issued a Cleared decision on January 2, 2013, 156 days after receiving the submission on July 30, 2012. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.5918.

Submission Details

510(k) Number K122273 FDA.gov
FDA Decision Cleared SESE
Date Received July 30, 2012
Decision Date January 02, 2013
Days to Decision 156 days
Submission Type Abbreviated
Review Panel Ophthalmic (OP)
Summary Summary PDF

Device Classification

Product Code MRC — Products, Contact Lens Care, Rigid Gas Permeable
Device Class Class II — Special Controls
CFR Regulation 21 CFR 886.5918

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