Cleared Traditional

Nutrifill

K181566 · Contamac, Ltd. · Ophthalmic
Oct 2018
Decision
130d
Days
Class 2
Risk

About This 510(k) Submission

K181566 is an FDA 510(k) clearance for the Nutrifill, a Products, Contact Lens Care, Rigid Gas Permeable (Class II — Special Controls, product code MRC), submitted by Contamac, Ltd. (Saffron Walden, GB). The FDA issued a Cleared decision on October 22, 2018, 130 days after receiving the submission on June 14, 2018. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.5918.

Submission Details

510(k) Number K181566 FDA.gov
FDA Decision Cleared SESE
Date Received June 14, 2018
Decision Date October 22, 2018
Days to Decision 130 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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