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510(k) K152960

ELAN 4 Motor System by Aesculap, Inc. — Product Code HBC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 22, 2016
Date Received
October 7, 2015
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Motor, Drill, Electric
Device Class
Class II
Regulation Number
882.4360
Review Panel
NE
Submission Type

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