Cleared Traditional

MEROCEL CORNELL LID AND LASH GUARD, MEROCEL AND KEROCEL OPHTHALMIC SPONGES

K011191 · Medtronic Xomed, Inc. · Ophthalmic
Jun 2001
Decision
68d
Days
Class 2
Risk

About This 510(k) Submission

K011191 is an FDA 510(k) clearance for the MEROCEL CORNELL LID AND LASH GUARD, MEROCEL AND KEROCEL OPHTHALMIC SPONGES, a Sponge, Ophthalmic (Class II — Special Controls, product code HOZ), submitted by Medtronic Xomed, Inc. (Jacksonville, US). The FDA issued a Cleared decision on June 26, 2001, 68 days after receiving the submission on April 19, 2001. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4790.

Submission Details

510(k) Number K011191 FDA.gov
FDA Decision Cleared SESE
Date Received April 19, 2001
Decision Date June 26, 2001
Days to Decision 68 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF

Device Classification

Product Code HOZ — Sponge, Ophthalmic
Device Class Class II — Special Controls
CFR Regulation 21 CFR 886.4790

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