Cleared Traditional

PARTIAL & TOTAL OSSICULAR REPLACEMENT PROSTHESIS

K963752 · Grace Medical, Inc. · Ear, Nose, Throat
Oct 1996
Decision
22d
Days
Class 2
Risk

About This 510(k) Submission

K963752 is an FDA 510(k) clearance for the PARTIAL & TOTAL OSSICULAR REPLACEMENT PROSTHESIS, 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 October 10, 1996, 22 days after receiving the submission on September 18, 1996. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.3450.

Submission Details

510(k) Number K963752 FDA.gov
FDA Decision Cleared SESE
Date Received September 18, 1996
Decision Date October 10, 1996
Days to Decision 22 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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