LERADO, COSCO

Wheelchair, Mechanical

LERADO OVERSEA LTD. TWN BRANCH (BVI)

The following data is part of a premarket notification filed by Lerado Oversea Ltd. Twn Branch (bvi) with the FDA for Lerado, Cosco.

Pre-market Notification Details

Device IDK050290
510k NumberK050290
Device Name:LERADO, COSCO
ClassificationWheelchair, Mechanical
Applicant LERADO OVERSEA LTD. TWN BRANCH (BVI) NO. 58, FU-CHIUN ST. Hsin-chu City,  TW 30067
ContactJen Ke-min
CorrespondentJen Ke-min
LERADO OVERSEA LTD. TWN BRANCH (BVI) NO. 58, FU-CHIUN ST. Hsin-chu City,  TW 30067
Product CodeIOR  
CFR Regulation Number890.3850 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2005-02-07
Decision Date2005-02-18
Summary:summary

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