FDA.report

510(k) K823912

Device
AUSTIN MODIFIED TOTAL OSSICULAR REPLACE
Applicant
TREACE MEDICAL, INC.
510(k) number
K823912
Product code
ETA  
Decision
Substantially Equivalent (SESE)
Decision date
1983-06-24
Date received
1982-12-28
Regulation
874.3495
Classification name
Replacement, Ossicular Prosthesis, Total
Medical specialty
Ear Nose & Throat
Review panel
Ear Nose & Throat
Device class
2
Clearance type
Traditional
Third party reviewed
No
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Address
803 N. Front St. Suite 3 Mchenry IL US 60050 60050

FDA Registration Numbers

Source Documents

FDA 510(k) Premarket Notification Database · 510(k) summary PDF not indicated by FDA · openFDA JSON

Related GUDID Devices

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00763000036508BojrabMEDTRONIC XOMED, INC.2021-11-07
00763000035464Sheehy / Polycel®MEDTRONIC XOMED, INC.2021-11-07
00681490035736SheehyMEDTRONIC XOMED, INC.2015-06-19
00681490023337LesinskiMEDTRONIC XOMED, INC.2015-06-15
00721902817427BojrabMEDTRONIC XOMED, INC.2015-06-15

Legacy Summary

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FDA Review

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