The following data is part of a premarket notification filed by Amigo Sales, Inc. with the FDA for All Terrain Amigo.
Device ID | K852557 |
510k Number | K852557 |
Device Name: | ALL TERRAIN AMIGO |
Classification | Vehicle, Motorized 3-wheeled |
Applicant | AMIGO SALES, INC. 6693 DIXIE HIGHWAY Bridgeport, MI 48722 |
Contact | Warren C Light |
Correspondent | Warren C Light AMIGO SALES, INC. 6693 DIXIE HIGHWAY Bridgeport, MI 48722 |
Product Code | INI |
CFR Regulation Number | 890.3800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1985-06-17 |
Decision Date | 1985-08-22 |