FDA.report

510(k) K833874

Device
SHEA MIDDLE EAR MICRODRILL
Applicant
APPLIED RESEARCH CORP.
510(k) number
K833874
Product code
ERL  
Decision
Substantially Equivalent (SESE)
Decision date
1984-06-22
Date received
1983-11-08
Regulation
874.4250
Classification name
Drill, Surgical, Ent (electric Or Pneumatic) Including Handpiece
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
4221 Richmond Rd., NW Walker MI US 49534 49534

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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00681490066907Skeeter®MEDTRONIC XOMED, INC.2016-09-29
00681490066846SKEETER®MEDTRONIC XOMED, INC.2016-05-02
00681490070348SKEETER®MEDTRONIC XOMED, INC.2016-04-23
00643169350670SKEETER®MEDTRONIC XOMED, INC.2016-04-07

Legacy Summary

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FDA Review

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