ENDO E CLASS

Controller, Foot, Handpiece And Cord

SAEYANG MICROTECH CO., LTD

The following data is part of a premarket notification filed by Saeyang Microtech Co., Ltd with the FDA for Endo E Class.

Pre-market Notification Details

Device IDK123608
510k NumberK123608
Device Name:ENDO E CLASS
ClassificationController, Foot, Handpiece And Cord
Applicant SAEYANG MICROTECH CO., LTD 55 NORTHERN BLVD Great Neck,  NY  11021
ContactJigar Shah
CorrespondentJigar Shah
SAEYANG MICROTECH CO., LTD 55 NORTHERN BLVD Great Neck,  NY  11021
Product CodeEBW  
CFR Regulation Number872.4200 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-11-21
Decision Date2013-08-16
Summary:summary

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