Cleared Traditional

CANAL WALL PROSTHESIS

K844960 · Richards Medical Co., Inc. · General & Plastic Surgery
Feb 1985
Decision
67d
Days
Class 2
Risk

About This 510(k) Submission

K844960 is an FDA 510(k) clearance for the CANAL WALL PROSTHESIS, a Prosthesis, Ear, Internal (Class II — Special Controls, product code FZD), submitted by Richards Medical Co., Inc. (Memphus, US). The FDA issued a Cleared decision on February 26, 1985, 67 days after receiving the submission on December 21, 1984. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.3590.

Submission Details

510(k) Number K844960 FDA.gov
FDA Decision Cleared SESE
Date Received December 21, 1984
Decision Date February 26, 1985
Days to Decision 67 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary —

Device Classification

Product Code FZD — Prosthesis, Ear, Internal
Device Class Class II — Special Controls
CFR Regulation 21 CFR 878.3590