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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 K203739
Device Name ELAN 4 Electro Motor System
Applicant
Aesculap Inc.
3773 Corporate Parkway
Center Valley,  PA  18034
Applicant Contact Kathy Racosky
Correspondent
Aesculap Inc.
3773 Corporate Parkway
Center Valley,  PA  18034
Correspondent Contact Kathy Racosky
Regulation Number882.4310
Classification Product Code
HBE  
Subsequent Product Code
HBC  
Date Received12/22/2020
Decision Date 08/24/2021
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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