Cleared Traditional

Menicon Saline Rinse Solution

K151768 · Menicon Co, Ltd. · Ophthalmic
Aug 2015
Decision
59d
Days
Class 2
Risk

About This 510(k) Submission

K151768 is an FDA 510(k) clearance for the Menicon Saline Rinse Solution, a Accessories, Soft Lens Products (Class II — Special Controls, product code LPN), submitted by Menicon Co, Ltd. (Nagoya, JP). The FDA issued a Cleared decision on August 28, 2015, 59 days after receiving the submission on June 30, 2015. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.5928.

Submission Details

510(k) Number K151768 FDA.gov
FDA Decision Cleared SESE
Date Received June 30, 2015
Decision Date August 28, 2015
Days to Decision 59 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF

Device Classification

Product Code LPN — Accessories, Soft Lens Products
Device Class Class II — Special Controls
CFR Regulation 21 CFR 886.5928

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