ELAN 4 Electro Motor System Tools

Drills, Burrs, Trephines & Accessories (simple, Powered)

Aesculap, Inc.

The following data is part of a premarket notification filed by Aesculap, Inc. with the FDA for Elan 4 Electro Motor System Tools.

Pre-market Notification Details

Device IDK172709
510k NumberK172709
Device Name:ELAN 4 Electro Motor System Tools
ClassificationDrills, Burrs, Trephines & Accessories (simple, Powered)
Applicant Aesculap, Inc. 3773 Corporate Parkway Center Valley,  PA  18034
ContactKathy A. Racosky
CorrespondentKathy A. Racosky
Aesculap, Inc. 3773 Corporate Parkway Center Valley,  PA  18034
Product CodeHBE  
CFR Regulation Number882.4310 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-09-08
Decision Date2018-10-17
Summary:summary

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