FDA 510(k) Application Details - K063581

Device Classification Name	Latex Patient Examination Glove   More FDA Info for this Device
510(K) Number	K063581
Device Name	Latex Patient Examination Glove
Applicant	PT MAHAKARYA INTI BUANA JL.SEI BELUMAI DESA DALU 10A DUSUN I TANJUNG MORAWA, SUMUT 20362 ID 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	11/30/2006
Decision Date	03/15/2007
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