The following data is part of a premarket notification filed by Dalton Medical Corp. with the FDA for Model Segaego 3d Scooter.
Device ID | K071284 |
510k Number | K071284 |
Device Name: | MODEL SEGAEGO 3D SCOOTER |
Classification | Vehicle, Motorized 3-wheeled |
Applicant | DALTON MEDICAL CORP. 1103 VENTURE CT. Carrollton, TX 75006 |
Contact | Will Ridgway |
Correspondent | Will Ridgway DALTON MEDICAL CORP. 1103 VENTURE CT. Carrollton, TX 75006 |
Product Code | INI |
CFR Regulation Number | 890.3800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2007-05-07 |
Decision Date | 2007-07-26 |