FDA 510(k) Application Details - K032016

Device Classification Name Latex Patient Examination Glove

  More FDA Info for this Device
510(K) Number K032016
Device Name Latex Patient Examination Glove
Applicant WRP SPECIALTY PRODUCTS SDN. BHD.
LOT 11, JALAN 2, KAWASAN
PERUSAHAAN BANDAR BARU SALAK
TINGGI, SEPANG, SELANGOR 43900 MY
Other 510(k) Applications for this Company
Contact V. NADARAJAN
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 06/30/2003
Decision Date 05/11/2004
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



Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact