Cleared Traditional

MICROMEDICS S&T PARTIAL OSSICULAR REPLACEMENT PROSTHESIS

K993234 · Micromedics, Inc. · Ear, Nose, Throat
Nov 1999
Decision
44d
Days
Class 2
Risk

About This 510(k) Submission

K993234 is an FDA 510(k) clearance for the MICROMEDICS S&T PARTIAL OSSICULAR REPLACEMENT PROSTHESIS, a Prosthesis, Partial Ossicular Replacement (Class II — Special Controls, product code ETB), submitted by Micromedics, Inc. (Eagan, US). The FDA issued a Cleared decision on November 10, 1999, 44 days after receiving the submission on September 27, 1999. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.3450.

Submission Details

510(k) Number K993234 FDA.gov
FDA Decision Cleared SESE
Date Received September 27, 1999
Decision Date November 10, 1999
Days to Decision 44 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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