The following data is part of a premarket notification filed by Shoprider Intl., Inc. with the FDA for Sovereign.
Device ID | K011476 |
510k Number | K011476 |
Device Name: | SOVEREIGN |
Classification | Vehicle, Motorized 3-wheeled |
Applicant | SHOPRIDER INTL., INC. P.O. BOX 187 Neodesha, KS 66757 |
Contact | Chris Tinsley |
Correspondent | Chris Tinsley SHOPRIDER INTL., INC. P.O. BOX 187 Neodesha, KS 66757 |
Product Code | INI |
CFR Regulation Number | 890.3800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2001-05-14 |
Decision Date | 2001-10-30 |