The following data is part of a premarket notification filed by Eurogreen International Inc with the FDA for Supascoota Motorized Vehicle.
Device ID | K143557 |
510k Number | K143557 |
Device Name: | SupaScoota Motorized Vehicle |
Classification | Vehicle, Motorized 3-wheeled |
Applicant | EUROGREEN INTERNATIONAL INC NO.48, LN.220, SEC.1, FUZUN RD., YUANLIN TOWNSHIP Changhua County, TW 51055 |
Contact | David Hsieh |
Correspondent | David Hsieh EUROGREEN INTERNATIONAL INC NO.48, LN.220, SEC.1, FUZUN RD., YUANLIN TOWNSHIP Changhua County, TW 51055 |
Product Code | INI |
CFR Regulation Number | 890.3800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2014-12-15 |
Decision Date | 2015-09-16 |
Summary: | summary |