Ballancer Gold, 1212

Massager, Powered Inflatable Tube

Mego Afek AC Ltd.

The following data is part of a premarket notification filed by Mego Afek Ac Ltd. with the FDA for Ballancer Gold, 1212.

Pre-market Notification Details

Device IDK190015
510k NumberK190015
Device Name:Ballancer Gold, 1212
ClassificationMassager, Powered Inflatable Tube
Applicant Mego Afek AC Ltd. Kibbutz Afek Kibbutz Afek,  IL 3004200
ContactReuven Yunger
CorrespondentIlan Sharon
Mego Afek AC Ltd. P.O. Box 4414 (A109) Caesarea,  IL 3088900
Product CodeIRP  
CFR Regulation Number890.5650 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-01-03
Decision Date2019-03-25

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