510(k) K971043

GOLDEN EAGLE by Golden Technologies, Inc. — Product Code INI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 1, 1997
Date Received
March 21, 1997
Clearance Type
Traditional
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