FDA 510(k) Application Details - K062764

Device Classification Name	Patient Examination Glove, Specialty   More FDA Info for this Device
510(K) Number	K062764
Device Name	Patient Examination Glove, Specialty
Applicant	KOSSAN LATEX INDUSTRIES(M)SDN BHD LOT 6129,JALAN HAJI ABDUL MANAN, OFF JALAN MERU KLANG, SELANGOR 41050 MY Other 510(k) Applications for this Company
Contact	LIM KWAN HWA Other 510(k) Applications for this Contact
Regulation Number	880.6250   More FDA Info for this Regulation Number
Classification Product Code	LZC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/15/2006
Decision Date	02/27/2007
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review