FDA 510(k) Application Details - K081907

Device Classification Name	Latex Patient Examination Glove   More FDA Info for this Device
510(K) Number	K081907
Device Name	Latex Patient Examination Glove
Applicant	SIAM SEMPERMED CORP. LTD. 13900 49TH STREET NORTH CLEARWATER, FL 33762 US Other 510(k) Applications for this Company
Contact	WILLIAM E HARRIS 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	07/03/2008
Decision Date	09/03/2008
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Abbreviated
Reviewed By Third Party	N
Expedited Review