510(k) K041025

BUZZAROUND, VEHICLE, MOTORIZED 3-WHEELED by Golden Technologies, Inc. — Product Code INI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 3, 2004
Date Received
April 21, 2004
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Vehicle, Motorized 3-Wheeled
Device Class
Class II
Regulation Number
890.3800
Review Panel
PM
Submission Type