Pobling MIITY 2

Stimulator, Transcutaneous Electrical, Aesthetic Purposes

HABALAN MED & BEAUTY CO.,LTD

The following data is part of a premarket notification filed by Habalan Med & Beauty Co.,ltd with the FDA for Pobling Miity 2.

Pre-market Notification Details

Device IDK163550
510k NumberK163550
Device Name:Pobling MIITY 2
ClassificationStimulator, Transcutaneous Electrical, Aesthetic Purposes
Applicant HABALAN MED & BEAUTY CO.,LTD 907, 219, GASANDIGITAL 1-RO, GEUMCHEON-GU Seoul,  KR 08501
ContactRay Jeon
CorrespondentPeter Chung
PLUS GLOBAL 300 ATWOOD Pittsburgh,  PA  15213
Product CodeNFO  
CFR Regulation Number882.5890 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-12-19
Decision Date2017-12-20

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