Cleared Traditional

MILLS COLUMELLA PROSTHESIS

K981088 · Exmoor Plastics , Ltd. · Ear, Nose, Throat
Jun 1998
Decision
72d
Days
Class 2
Risk

About This 510(k) Submission

K981088 is an FDA 510(k) clearance for the MILLS COLUMELLA PROSTHESIS, a Replacement, Ossicular Prosthesis, Total (Class II — Special Controls, product code ETA), submitted by Exmoor Plastics , Ltd. (Taunton, GB). The FDA issued a Cleared decision on June 5, 1998, 72 days after receiving the submission on March 25, 1998. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.3495.

Submission Details

510(k) Number K981088 FDA.gov
FDA Decision Cleared SESE
Date Received March 25, 1998
Decision Date June 05, 1998
Days to Decision 72 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF

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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