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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name motor, drill, electric
510(k) Number K152960
Device Name ELAN 4 Motor System
Applicant
AESCULAP, INC.
3773 CORPORATE PARKWAY
CENTER VALLEY,  PA  18034
Applicant Contact PETER STOLL
Correspondent
AESCULAP, INC.
3773 CORPORATE PARKWAY
CENTER VALLEY,  PA  18034
Correspondent Contact PETER STOLL
Regulation Number882.4360
Classification Product Code
HBC  
Date Received10/07/2015
Decision Date 07/22/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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