LANDLEX, MODEL: 402X

Vehicle, Motorized 3-wheeled

BESTEAM TECHNOLOGY INC.

The following data is part of a premarket notification filed by Besteam Technology Inc. with the FDA for Landlex, Model: 402x.

Pre-market Notification Details

Device IDK083303
510k NumberK083303
Device Name:LANDLEX, MODEL: 402X
ClassificationVehicle, Motorized 3-wheeled
Applicant BESTEAM TECHNOLOGY INC. 14F-2 NO. 1 LANE 25 ZHUANGJING RD. Banqiao,  TW 220
ContactJunnata Chang
CorrespondentJunnata Chang
BESTEAM TECHNOLOGY INC. 14F-2 NO. 1 LANE 25 ZHUANGJING RD. Banqiao,  TW 220
Product CodeINI  
CFR Regulation Number890.3800 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2008-11-10
Decision Date2009-01-26
Summary:summary

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.