Stimulator, Muscle, Powered

EGZOTech Sp. Z O. O.

The following data is part of a premarket notification filed by Egzotech Sp. Z O. O. with the FDA for Stella Bio.

Pre-market Notification Details

Device IDK210002
510k NumberK210002
Device Name:STELLA BIO
ClassificationStimulator, Muscle, Powered
Applicant EGZOTech Sp. Z O. O. Romualda Traugutta 6H Gliwice,  PL 44-100
ContactMichal Mikulski
CorrespondentVaibhav Arvind Rajal
mdi Consultants, Inc. 55 Northern Blvd., Suite 200 Great Neck,  NY  11021
Product CodeIPF  
Subsequent Product CodeGZI
Subsequent Product CodeGZJ
Subsequent Product CodeHCC
Subsequent Product CodeKPI
Subsequent Product CodeNGX
Subsequent Product CodeNUH
Subsequent Product CodeNYN
CFR Regulation Number890.5850 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-01-04
Decision Date2021-10-01

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