FDA.reportPublic FDA data

510(k) K863939

Device
POREX(TM) EAR PROSTHESIS
Applicant
POREX MEDICAL
510(k) number
K863939
Product code
FZD  
Decision
Substantially Equivalent (SESE)
Decision date
1986-10-24
Date received
1986-10-10
Regulation
878.3590
Classification name
Prosthesis, Ear, Internal
Medical specialty
General & Plastic Surgery
Review panel
General & Plastic Surgery
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
HOWARD A MERCER,PHD
Address
500 Bohannon Rd. Fairburn GA US 30213 30213

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code FZD  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K172389ePTFE-Coated Auricular ImplantImplantech Associates, Inc.2018-07-18
K844960CANAL WALL PROSTHESISRichards Medical Co., Inc.1985-02-26

Legacy Summary#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases

FDA Review#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases