Cleared Special

STAPES PROSTHESES

K991394 · Grace Medical, Inc. · Ear, Nose, Throat
May 1999
Decision
27d
Days
Class 2
Risk

About This 510(k) Submission

K991394 is an FDA 510(k) clearance for the STAPES PROSTHESES, a Prosthesis, Partial Ossicular Replacement (Class II — Special Controls, product code ETB), submitted by Grace Medical, Inc. (Bartlett, US). The FDA issued a Cleared decision on May 18, 1999, 27 days after receiving the submission on April 21, 1999. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.3450.

Submission Details

510(k) Number K991394 FDA.gov
FDA Decision Cleared SESE
Date Received April 21, 1999
Decision Date May 18, 1999
Days to Decision 27 days
Submission Type Special
Review Panel Ear, Nose, Throat (EN)
Summary Statement

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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