ELAN 4 Motor System

Motor, Drill, Electric

AESCULAP, INC.

The following data is part of a premarket notification filed by Aesculap, Inc. with the FDA for Elan 4 Motor System.

Pre-market Notification Details

Device IDK152960
510k NumberK152960
Device Name:ELAN 4 Motor System
ClassificationMotor, Drill, Electric
Applicant AESCULAP, INC. 3773 CORPORATE PARKWAY Center Valley,  PA  18034
ContactPeter Stoll
CorrespondentPeter Stoll
AESCULAP, INC. 3773 CORPORATE PARKWAY Center Valley,  PA  18034
Product CodeHBC  
CFR Regulation Number882.4360 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-10-07
Decision Date2016-07-22
Summary:summary

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