FDA 510(k) Application Details - K031913

Device Classification Name	Vinyl Patient Examination Glove   More FDA Info for this Device
510(K) Number	K031913
Device Name	Vinyl Patient Examination Glove
Applicant	ARISTA LATINDO INDUSTRIAL, LTD. P.T. 128 JALAN KYAI HAJI MUHAMMAD MANSYUR JAKARTA BARAT 11210 ID Other 510(k) Applications for this Company
Contact	LINGA SUMARTA Other 510(k) Applications for this Contact
Regulation Number	880.6250   More FDA Info for this Regulation Number
Classification Product Code	LYZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/20/2003
Decision Date	07/09/2003
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review