FDA 510(k) Application Details - K982158

Device Classification Name	Wheelchair, Powered   More FDA Info for this Device
510(K) Number	K982158
Device Name	Wheelchair, Powered
Applicant	BURKE, INC. 1800 MERRIAM LN. KANSAS CITY, KS 66106 US Other 510(k) Applications for this Company
Contact	DUWAYNE E KRAMER Other 510(k) Applications for this Contact
Regulation Number	890.3860   More FDA Info for this Regulation Number
Classification Product Code	ITI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/19/1998
Decision Date	08/31/1998
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