FDA.report

510(k) K172709

Device
ELAN 4 Electro Motor System Tools
Applicant
Aesculap, Inc.
510(k) number
K172709
Product code
HBE  
Decision
Substantially Equivalent (SESE)
Decision date
2018-10-17
Date received
2017-09-08
Regulation
882.4310
Classification name
Drills, Burrs, Trephines & Accessories (simple, Powered)
Medical specialty
Neurology
Review panel
Neurology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
Kathy A. Racosky
Address
3773 Corporate Pkwy. Center Valley PA US 18034 18034

FDA Registration Numbers

Source Documents

FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON

Legacy Summary

summary

FDA Review

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