Cleared Traditional

MICROTEK TOTAL OSSICULAR PROTHESIS

K895815 · Microbio-Medics, Inc. · Ear, Nose, Throat
Dec 1989
Decision
88d
Days
Class 2
Risk

About This 510(k) Submission

K895815 is an FDA 510(k) clearance for the MICROTEK TOTAL OSSICULAR PROTHESIS, a Replacement, Ossicular Prosthesis, Total (Class II — Special Controls, product code ETA), submitted by Microbio-Medics, Inc. (Columbus, US). The FDA issued a Cleared decision on December 26, 1989, 88 days after receiving the submission on September 29, 1989. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.3495.

Submission Details

510(k) Number K895815 FDA.gov
FDA Decision Cleared SESE
Date Received September 29, 1989
Decision Date December 26, 1989
Days to Decision 88 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary —

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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