FDA 510(k) Application Details - K990677

Device Classification Name	Patient Examination Glove, Specialty   More FDA Info for this Device
510(K) Number	K990677
Device Name	Patient Examination Glove, Specialty
Applicant	AMPRI RUBBERWARE INDUSTRIES SDN BHD LOT B5 & B6, PHASE II, KAWASAN PERINDUSTRIAN MIEL BATANG KALI, SELANGOR 44300 MY Other 510(k) Applications for this Company
Contact	LI KIM PHNG 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	03/02/1999
Decision Date	11/01/1999
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