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510(k) K844960

Device
CANAL WALL PROSTHESIS
Applicant
RICHARDS MEDICAL CO., INC.
510(k) number
K844960
Product code
FZD  
Decision
Substantially Equivalent (SESE)
Decision date
1985-02-26
Date received
1984-12-21
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
ROBERT F GAMES
Address
1450 Brooks Rd. Memphis TN US 38116 38116

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
K863939POREX(TM) EAR PROSTHESISPorex Medical1986-10-24

Legacy Summary#

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FDA Review#

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