KTA Adipose Treatment Kit

System, Suction, Lipoplasty

Stemics S.A.S

The following data is part of a premarket notification filed by Stemics S.a.s with the FDA for Kta Adipose Treatment Kit.

Pre-market Notification Details

Device IDK190386
510k NumberK190386
Device Name:KTA Adipose Treatment Kit
ClassificationSystem, Suction, Lipoplasty
Applicant Stemics S.A.S 2 Rue Professeur Paul Milleret Besancon,  FR 25000
ContactStephane Giraud
CorrespondentCatherine Gloster
Gloster Biomedical International, LLC 577 North Hope Avenue Santa Barbara,  CA  93110
Product CodeMUU  
CFR Regulation Number878.5040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-02-19
Decision Date2019-10-10
Summary:summary

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