FDA 510(k) Application Details - K050575

Device Classification Name	Instrument, Manual, Surgical, General Use   More FDA Info for this Device
510(K) Number	K050575
Device Name	Instrument, Manual, Surgical, General Use
Applicant	FUTUMEDS SDN BHD NO. 3, JALAN PUCHONG, BATU 12 1/2 PUCHONG 47100 MY Other 510(k) Applications for this Company
Contact	LEONG PEI PING Other 510(k) Applications for this Contact
Regulation Number	878.4800   More FDA Info for this Regulation Number
Classification Product Code	MDM Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/07/2005
Decision Date	08/15/2005
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review