LX9max

Massager, Powered Inflatable Tube

Daesung Maref CO., LTD.

The following data is part of a premarket notification filed by Daesung Maref Co., Ltd. with the FDA for Lx9max.

Pre-market Notification Details

Device IDK203498
510k NumberK203498
Device Name:LX9max
ClassificationMassager, Powered Inflatable Tube
Applicant Daesung Maref CO., LTD. 298-24, Gongdan-Ro Gunpo-si,  KR 15809
ContactSu Hyeon So
CorrespondentSu Hyeon So
Daesung Maref CO., LTD. 298-24, Gongdan-Ro Gunpo-si,  KR 15809
Product CodeIRP  
CFR Regulation Number890.5650 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-11-27
Decision Date2021-07-02

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