FDA.reportPublic FDA data

510(k) K834094

Device
AUSTIN ENDOLYMPH DISPERSMENT SHUNT
Applicant
TREACE MEDICAL, INC.
510(k) number
K834094
Product code
ESZ  
Decision
Substantially Equivalent (SESE)
Decision date
1984-09-20
Date received
1983-11-28
Regulation
874.3820
Classification name
Tube, Shunt, Endolymphatic
Medical specialty
Ear Nose & Throat
Review panel
Ear Nose & Throat
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Address
4221 Richmond Rd., NW Walker MI US 49534 49534

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code ESZ  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K974224ENDOLYMPHATIC SAC TO MASTOID T-SHUNTExmoor Plastics , Ltd.1998-01-27
K952227C-FLEX ENDOLYMPHATIC SHUNTTrebay Medical Corp.1995-06-16
K897049GIBSON ENDOLYMPHATIC SHUNTHood Laboratories1990-03-16

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