Cleared Traditional

MENICON PROGENT REMOVER FOR RIGID GAS PERMEABLE CONTACT LENSES

K020930 · Menicon Co, Ltd. · Ophthalmic
May 2002
Decision
41d
Days
Class 2
Risk

About This 510(k) Submission

K020930 is an FDA 510(k) clearance for the MENICON PROGENT REMOVER FOR RIGID GAS PERMEABLE CONTACT LENSES, 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 May 2, 2002, 41 days after receiving the submission on March 22, 2002. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.5918.

Submission Details

510(k) Number K020930 FDA.gov
FDA Decision Cleared SESE
Date Received March 22, 2002
Decision Date May 02, 2002
Days to Decision 41 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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