FDA 510(k) Application Details - K090735

Device Classification Name Vehicle, Motorized 3-Wheeled

  More FDA Info for this Device
510(K) Number K090735
Device Name Vehicle, Motorized 3-Wheeled
Applicant C.T.M. HOMECARE PRODUCT, INC.
29611 SIMMONS ROAD
EUGENE, OR 97405 US
Other 510(k) Applications for this Company
Contact LINDA J BOVARD
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 03/19/2009
Decision Date 07/06/2009
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



Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact