Cleared Traditional

MENICON PROGENT REMOVER

K002140 · Menicon Co, Ltd. · Ophthalmic
Oct 2000
Decision
85d
Days
Class 2
Risk

About This 510(k) Submission

K002140 is an FDA 510(k) clearance for the MENICON PROGENT REMOVER, 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 October 10, 2000, 85 days after receiving the submission on July 17, 2000. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.5918.

Submission Details

510(k) Number K002140 FDA.gov
FDA Decision Cleared SESE
Date Received July 17, 2000
Decision Date October 10, 2000
Days to Decision 85 days
Submission Type Traditional
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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