Nutrifill— 510(k) K181566

Substantially Equivalent

Contamac, Ltd.

FDA 510(k) clearance K181566 for Nutrifill, Substantially Equivalent on 2018-10-22. Applicant: Contamac, Ltd.. Device class: 2.

Clearance details

Applicant: Contamac, Ltd.
Product code: Code MRC
Device class: Class 2
Regulation: 21 CFR 886.5918
Advisory panel: Ophthalmic
Date received: 2018-06-14
Decision date: 2018-10-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Saffron Walden, GB

Download summary PDF View on FDA.gov ↗

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More clearances from Contamac, Ltd.

Recalls naming K181566

K-number listed on FDA's recall record

Z-1956-2025 — Contamac, Nutrifill Physiologic formula, Contact Lens Insertion solutionClass II·Ongoing·Contamac Solutions, Inc.·20250515
Z-0030-2022 — Nutrifill Scleral, Hybrid, and Gas Permeable (GP) Lens Insertion Solution, Physiologic Formula, Preservative Free, 35 Single-use 10ml ampoules (360ml), UDI:00850012123002Class II·Terminated·Contamac Solutions, Inc.·20210727

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K181566.

Data sourced from openFDA. This site is unofficial and independent of the FDA.