FDA 510(k) Application Details - K011753

Device Classification Name	Vehicle, Motorized 3-Wheeled   More FDA Info for this Device
510(K) Number	K011753
Device Name	Vehicle, Motorized 3-Wheeled
Applicant	MERITS HEALTH PRODUCTS., INC. P.O. BOX 150356 CAPE CORAL, FL 33915 US Other 510(k) Applications for this Company
Contact	WINSTON ANDERSON 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	06/06/2001
Decision Date	08/03/2001
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	PM - Physical Medicine
Review Advisory Committee	PM - Physical Medicine
Statement / Summary / Purged Status	Statement
Type	Special
Reviewed By Third Party	N
Expedited Review