Cleared Traditional

TITANIUM MIDDLE EAR PROSTHESES

K002897 · Xomed, Inc. · Ear, Nose, Throat
Oct 2000
Decision
23d
Days
Class 2
Risk

About This 510(k) Submission

K002897 is an FDA 510(k) clearance for the TITANIUM MIDDLE EAR PROSTHESES, a Prosthesis, Partial Ossicular Replacement (Class II — Special Controls, product code ETB), submitted by Xomed, Inc. (Jacksonville, US). The FDA issued a Cleared decision on October 11, 2000, 23 days after receiving the submission on September 18, 2000. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.3450.

Submission Details

510(k) Number K002897 FDA.gov
FDA Decision Cleared SESE
Date Received September 18, 2000
Decision Date October 11, 2000
Days to Decision 23 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF

Device Classification

Product Code ETB — Prosthesis, Partial Ossicular Replacement
Device Class Class II — Special Controls
CFR Regulation 21 CFR 874.3450

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