SP-1000, SP-2000

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 Sp-1000, Sp-2000.

Pre-market Notification Details

Device IDK202395
510k NumberK202395
Device Name:SP-1000, SP-2000
ClassificationMassager, Powered Inflatable Tube
Applicant DaeSung Maref Co., Ltd 298-24, Gongdan-ro Gunpo-si,  KR 15809
ContactHyoung Ju Cho
CorrespondentDo Gyun Lim
Global Medical Standard Consulting Co., Ltd. 34, Sangamsan-ro, Mapo-gu Seoul,  KR 03909
Product CodeIRP  
CFR Regulation Number890.5650 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-08-21
Decision Date2021-09-01

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