Cleared Traditional

PARTIAL OSSICULAR REPLACEMENT PROSTHESES

K060518 · Grace Medical, Inc. · Ear, Nose, Throat
Jun 2006
Decision
121d
Days
Class 2
Risk

About This 510(k) Submission

K060518 is an FDA 510(k) clearance for the PARTIAL OSSICULAR REPLACEMENT PROSTHESES, a Prosthesis, Partial Ossicular Replacement (Class II — Special Controls, product code ETB), submitted by Grace Medical, Inc. (Memphis, US). The FDA issued a Cleared decision on June 28, 2006, 121 days after receiving the submission on February 27, 2006. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.3450.

Submission Details

510(k) Number K060518 FDA.gov
FDA Decision Cleared SESE
Date Received February 27, 2006
Decision Date June 28, 2006
Days to Decision 121 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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