FDA 510(k) Application Details - K010483

Device Classification Name	Latex Patient Examination Glove   More FDA Info for this Device
510(K) Number	K010483
Device Name	Latex Patient Examination Glove
Applicant	PT. MEDISAFE TECHNOLOGIES JL. LET-JEN. S. PARMAN NO. 23/235 MEDAN 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	LYY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/20/2001
Decision Date	05/03/2001
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Statement
Type	Special
Reviewed By Third Party	N
Expedited Review