FDA 510(k) Application Details - K060043

Device Classification Name	Manipulator, Plunger-Like Joint   More FDA Info for this Device
510(K) Number	K060043
Device Name	Manipulator, Plunger-Like Joint
Applicant	OPTIMA HEALTH SOLUTIONS INTERNATIONAL, INC. UNIT 303, 828 WEST 8TH AVE. VANCOUVER, BRITISH COLUMBIA V5Z 1E2 CA Other 510(k) Applications for this Company
Contact	BRAM RAMJIAWAN Other 510(k) Applications for this Contact
Regulation Number	000.0000   More FDA Info for this Regulation Number
Classification Product Code	LXM Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/06/2006
Decision Date	03/23/2006
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	-
Review Advisory Committee	PM - Physical Medicine
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review