POREX(TM) EAR PROSTHESIS— 510(k) K863939

Substantially Equivalent

Porex Medical

FDA 510(k) clearance K863939 for POREX(TM) EAR PROSTHESIS, Substantially Equivalent on 1986-10-24. Applicant: Porex Medical. Device class: 2.

Clearance details

Applicant: Porex Medical
Product code: Code FZD
Device class: Class 2
Regulation: 21 CFR 878.3590
Advisory panel: General, Plastic Surgery
Date received: 1986-10-10
Decision date: 1986-10-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Fairburn, GA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code FZD

K172389 — ePTFE-Coated Auricular Implant2018-07-18
K844960 — CANAL WALL PROSTHESIS1985-02-26

More clearances from Porex Medical

K872791 — POREX NERVE LOCATOR1987-10-20
K873044 — POREX OTOLOGY INSTRUMENTS1987-09-04
K872947 — POREX QUALITY PLASTIC SURGERY INSTRUMENTS1987-08-21
K863943 — POREX(TM) EYE SPHERE IMPLANT1987-02-27
K863946 — POREX(TM) EXTRA-OCULAR ORBITAL IMPLANT1987-02-27

Data sourced from openFDA. This site is unofficial and independent of the FDA.