ELAN 4 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 Tools.

Pre-market Notification Details

Device IDK183203
510k NumberK183203
Device Name:ELAN 4 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 Received2018-11-19
Decision Date2019-08-09

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