FDA 510(k) Application Details - K040607

Device Classification Name	Polymer Patient Examination Glove   More FDA Info for this Device
510(K) Number	K040607
Device Name	Polymer Patient Examination Glove
Applicant	PT. MEDISAFE TECHNOLOGIES JL. KAPT. PATTIMURA NO. 23 MEDAN, NORTH SUMATRA 20153 ID Other 510(k) Applications for this Company
Contact	ANIL TANEJA Other 510(k) Applications for this Contact
Regulation Number	880.6250   More FDA Info for this Regulation Number
Classification Product Code	LZA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/08/2004
Decision Date	04/22/2004
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