FDA 510(k) Application Details - K070619

Device Classification Name	Surgeon'S Gloves   More FDA Info for this Device
510(K) Number	K070619
Device Name	Surgeon'S Gloves
Applicant	WRP ASIA PACIFIC SDN. BHD. LOT1,JALAN3,KAWASAN PERUSAHAAN BANDAR BARU SALAK TINGGI SEPANG,SELANGOR DARUL EHSAN 43900 MY Other 510(k) Applications for this Company
Contact	KIRK PENNER 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	03/05/2007
Decision Date	06/27/2007
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review