Cleared Traditional

MENICON UNIQUE PH MULTI-PURPOSE SOLUTION

K130805 · Menicon Co, Ltd. · Ophthalmic
Jul 2013
Decision
100d
Days
Class 2
Risk

About This 510(k) Submission

K130805 is an FDA 510(k) clearance for the MENICON UNIQUE PH MULTI-PURPOSE SOLUTION, 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 July 3, 2013, 100 days after receiving the submission on March 25, 2013. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.5918.

Submission Details

510(k) Number K130805 FDA.gov
FDA Decision Cleared SESE
Date Received March 25, 2013
Decision Date July 03, 2013
Days to Decision 100 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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