Cleared Traditional

OTOMIMIX

K042516 · Walter Lorenz Surgical, Inc. · Ear, Nose, Throat
Nov 2004
Decision
53d
Days
Class 2
Risk

About This 510(k) Submission

K042516 is an FDA 510(k) clearance for the OTOMIMIX, a Cement, Ear, Nose And Throat (Class II — Special Controls, product code NEA), submitted by Walter Lorenz Surgical, Inc. (Jacksonville, US). The FDA issued a Cleared decision on November 8, 2004, 53 days after receiving the submission on September 16, 2004. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 872.3275.

Submission Details

510(k) Number K042516 FDA.gov
FDA Decision Cleared SESE
Date Received September 16, 2004
Decision Date November 08, 2004
Days to Decision 53 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF

Device Classification

Product Code NEA — Cement, Ear, Nose And Throat
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.3275