FDA 510(k) Application Details - K954974

Device Classification Name	Vehicle, Motorized 3-Wheeled   More FDA Info for this Device
510(K) Number	K954974
Device Name	Vehicle, Motorized 3-Wheeled
Applicant	BURKE MOBILITY PRODUCTS P.O. BOX 1064 MISSION, KS 66222 US Other 510(k) Applications for this Company
Contact	DUWAYNE KRAMER Other 510(k) Applications for this Contact
Regulation Number	890.3800   More FDA Info for this Regulation Number
Classification Product Code	INI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/25/1995
Decision Date	03/19/1996
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	PM - Physical Medicine
Review Advisory Committee	PM - Physical Medicine
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review