The following data is part of a premarket notification filed by Sunpex Technology Co., Ltd. with the FDA for Sunpex Technologies Model Se03.
Device ID | K033019 |
510k Number | K033019 |
Device Name: | SUNPEX TECHNOLOGIES MODEL SE03 |
Classification | Vehicle, Motorized 3-wheeled |
Applicant | SUNPEX TECHNOLOGY CO., LTD. 914 WEST PATAPSCO AVE. Baltimore, MD 21230 |
Contact | Leonard Frier |
Correspondent | Leonard Frier SUNPEX TECHNOLOGY CO., LTD. 914 WEST PATAPSCO AVE. Baltimore, MD 21230 |
Product Code | INI |
CFR Regulation Number | 890.3800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Abbreviated |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2003-09-26 |
Decision Date | 2004-01-22 |