FDA 510(k) Application Details - K980107

Device Classification Name	Wheelchair, Mechanical   More FDA Info for this Device
510(K) Number	K980107
Device Name	Wheelchair, Mechanical
Applicant	RUNCH GROUP USA, INC. 2401 FOUNTAINVIEW, SUITE 802 HOUSTON, TX 77057 US Other 510(k) Applications for this Company
Contact	HILARIO E MATA Other 510(k) Applications for this Contact
Regulation Number	890.3850   More FDA Info for this Regulation Number
Classification Product Code	IOR Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/12/1998
Decision Date	02/19/1998
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