FDA 510(k) Application Details - K073447

Device Classification Name	Surgeon'S Gloves   More FDA Info for this Device
510(K) Number	K073447
Device Name	Surgeon'S Gloves
Applicant	METACURE SURGICAL GLOVES SDN BHD NO. 1, JLN 203, OFF JALAN TANDANG PETALING JAYA 46050 MY Other 510(k) Applications for this Company
Contact	JEFRI SHARAAI Other 510(k) Applications for this Contact
Regulation Number	878.4460   More FDA Info for this Regulation Number
Classification Product Code	KGO Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/07/2007
Decision Date	04/24/2008
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review