KI-20

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 Ki-20.

Pre-market Notification Details

Device IDK141482
510k NumberK141482
Device Name:KI-20
ClassificationController, Foot, Handpiece And Cord
Applicant SAEYANG MICROTECH CO LTD 2651 E.CHAPMAN AVE STE 110 Fullerton,  CA  92831
ContactPriscilla Chung
CorrespondentPriscilla Chung
SAEYANG MICROTECH CO LTD 2651 E.CHAPMAN AVE STE 110 Fullerton,  CA  92831
Product CodeEBW  
CFR Regulation Number872.4200 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-06-04
Decision Date2015-04-24
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
08809394970881 K141482 000

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