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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Drills, Burrs, Trephines & Accessories (Simple, Powered)
510(k) Number K183203
Device Name ELAN 4 Tools
Applicant
Aesculap, Inc.
3 773 Corporate Pkwy.
Center Valley,  PA  18034
Applicant Contact Kathy A. Racosky
Correspondent
Aesculap, Inc.
3 773 Corporate Pkwy.
Center Valley,  PA  18034
Correspondent Contact Kathy A. Racosky
Regulation Number882.4310
Classification Product Code
HBE  
Date Received11/19/2018
Decision Date 08/09/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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