FDA 510(k) Application Details - K031669

Device Classification Name	Surgeon'S Gloves   More FDA Info for this Device
510(K) Number	K031669
Device Name	Surgeon'S Gloves
Applicant	P.T. SAPTINDO SURGICA JALAN RAYA SERANG KM 65, CIKANDE SERANG-BANTEN 42186 ID Other 510(k) Applications for this Company
Contact	WIDAGDO GONDOWARDOYO 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	05/29/2003
Decision Date	09/23/2003
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review