Cleared Traditional

GRACE DYNAMIC TORP

K091187 · Grace Medical, Inc. · Ear, Nose, Throat
Sep 2009
Decision
144d
Days
Class 2
Risk

About This 510(k) Submission

K091187 is an FDA 510(k) clearance for the GRACE DYNAMIC TORP, a Replacement, Ossicular Prosthesis, Total (Class II — Special Controls, product code ETA), submitted by Grace Medical, Inc. (Memphis, US). The FDA issued a Cleared decision on September 14, 2009, 144 days after receiving the submission on April 23, 2009. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.3495.

Submission Details

510(k) Number K091187 FDA.gov
FDA Decision Cleared SESE
Date Received April 23, 2009
Decision Date September 14, 2009
Days to Decision 144 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF

Device Classification

Product Code ETA — Replacement, Ossicular Prosthesis, Total
Device Class Class II — Special Controls
CFR Regulation 21 CFR 874.3495

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