FDA 510(k) Application Details - K110395

Device Classification Name	Vehicle, Motorized 3-Wheeled   More FDA Info for this Device
510(K) Number	K110395
Device Name	Vehicle, Motorized 3-Wheeled
Applicant	C.T.M. HOMECARE PRODUCT, INC. 927 THRONE DRIVE EUGENE, OR 97402 US Other 510(k) Applications for this Company
Contact	SHEILA RAMERMAN 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	02/11/2011
Decision Date	04/22/2011
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