FDA 510(k) Application Details - K083409

Device Classification Name	Patient Examination Glove, Specialty   More FDA Info for this Device
510(K) Number	K083409
Device Name	Patient Examination Glove, Specialty
Applicant	WRP ASIA PACIFIC SDN. BHD. LOT 1, JALAN 3, KAWASAN PERUSAHAAN BANDAR BARU SALAK TINGGI, SEPANG SELANGOR 43900 MY Other 510(k) Applications for this Company
Contact	KIRK PENNER 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	11/18/2008
Decision Date	07/29/2009
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