FDA 510(k) Application Details - K051562

Device Classification Name	Surgeon'S Gloves   More FDA Info for this Device
510(K) Number	K051562
Device Name	Surgeon'S Gloves
Applicant	TERANG NUSA SDN BHD 1, JALAN 8, PENGKALAN CHEPA 2 IND. ZONE KOTA BHARU, KELANTAN 16100 MY Other 510(k) Applications for this Company
Contact	CHIN-GUAN LOW 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	06/13/2005
Decision Date	10/20/2005
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