FDA 510(k) Application Details - K970773

Device Classification Name	Latex Patient Examination Glove   More FDA Info for this Device
510(K) Number	K970773
Device Name	Latex Patient Examination Glove
Applicant	PT. SARANA INDOPROTEX JL. IR. SUTAMI KM. 07 PO BOX 214 TNK, BANDAR LAMPUNG 35001 35001 ID Other 510(k) Applications for this Company
Contact	MD YUSOF BIN IBRAHIM Other 510(k) Applications for this Contact
Regulation Number	880.6250   More FDA Info for this Regulation Number
Classification Product Code	LYY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/04/1997
Decision Date	12/04/1997
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