FDA 510(k) Application Details - K001923

Device Classification Name	Wheelchair, Powered   More FDA Info for this Device
510(K) Number	K001923
Device Name	Wheelchair, Powered
Applicant	GENDRON, INC. 400 EAST LUGBILL RD. P.O. BOX 0197 ARCHBOLD, OH 43502-0197 US Other 510(k) Applications for this Company
Contact	FREDERIC W STROBEL 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	06/23/2000
Decision Date	08/25/2000
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	PM - Physical Medicine
Review Advisory Committee	PM - Physical Medicine
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review