Cleared Traditional

POREX(TM) EAR PROSTHESIS

K863939 · Porex Medical · General & Plastic Surgery
Oct 1986
Decision
14d
Days
Class 2
Risk

About This 510(k) Submission

K863939 is an FDA 510(k) clearance for the POREX(TM) EAR PROSTHESIS, a Prosthesis, Ear, Internal (Class II — Special Controls, product code FZD), submitted by Porex Medical (Fairburn, US). The FDA issued a Cleared decision on October 24, 1986, 14 days after receiving the submission on October 10, 1986. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.3590.

Submission Details

510(k) Number K863939 FDA.gov
FDA Decision Cleared SESE
Date Received October 10, 1986
Decision Date October 24, 1986
Days to Decision 14 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