The following data is part of a premarket notification filed by Lerado China Limited with the FDA for Leradotech, Model Sc.
Device ID | K070802 |
510k Number | K070802 |
Device Name: | LERADOTECH, MODEL SC |
Classification | Vehicle, Motorized 3-wheeled |
Applicant | LERADO CHINA LIMITED 14F-2, NO. 1, ZHUANGJING RD. LANE 25 Banqiao, Taipei County, TW |
Contact | Junnata Chang |
Correspondent | Junnata Chang LERADO CHINA LIMITED 14F-2, NO. 1, ZHUANGJING RD. LANE 25 Banqiao, Taipei County, TW |
Product Code | INI |
CFR Regulation Number | 890.3800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2007-03-23 |
Decision Date | 2007-04-13 |
Summary: | summary |