Cleared Traditional

PARTIAL/TOTAL/POROUS POLYETHYLENE OSSICULAR REPLACEMENT

K972815 · Grace Medical, Inc. · Ear, Nose, Throat
Oct 1997
Decision
72d
Days
Class 2
Risk

About This 510(k) Submission

K972815 is an FDA 510(k) clearance for the PARTIAL/TOTAL/POROUS POLYETHYLENE OSSICULAR REPLACEMENT, 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 October 8, 1997, 72 days after receiving the submission on July 28, 1997. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.3450.

Submission Details

510(k) Number K972815 FDA.gov
FDA Decision Cleared SESE
Date Received July 28, 1997
Decision Date October 08, 1997
Days to Decision 72 days
Submission Type Traditional
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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