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510(k) K172389

Device
EPTFE-Coated Auricular Implant
Applicant
Implantech Associates Inc.
510(k) number
K172389
Product code
FZD  
Decision
Substantially Equivalent (SESE)
Decision date
2018-07-18
Date received
2017-08-08
Regulation
878.3590
Classification name
Prosthesis, Ear, Internal
Medical specialty
General & Plastic Surgery
Review panel
General & Plastic Surgery
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Craig Arthur
Address
6025 Nicolle St., Suite B Ventura CA US 93003 93003

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code FZD  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K863939POREX(TM) EAR PROSTHESISPorex Medical1986-10-24
K844960CANAL WALL PROSTHESISRichards Medical Co., Inc.1985-02-26

Legacy Summary#

summary

FDA Review#

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