The following data is part of a premarket notification filed by Ever Prosperous Instrument Inc with the FDA for Lordex Power Traction Equipment.
Device ID | K031227 |
510k Number | K031227 |
Device Name: | LORDEX POWER TRACTION EQUIPMENT |
Classification | Equipment, Traction, Powered |
Applicant | EVER PROSPEROUS INSTRUMENT INC 15915 KATY FREEWAY SUITE 645 Houston, TX 77094 |
Contact | John Boren |
Correspondent | John Boren EVER PROSPEROUS INSTRUMENT INC 15915 KATY FREEWAY SUITE 645 Houston, TX 77094 |
Product Code | ITH |
CFR Regulation Number | 890.5900 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2003-04-18 |
Decision Date | 2003-07-17 |