FDA 510(k) Application Details - K002391

Device Classification Name	Polymer Patient Examination Glove   More FDA Info for this Device
510(K) Number	K002391
Device Name	Polymer Patient Examination Glove
Applicant	SIAM SEMPERMED CORP. LTD. 30798 US HWY 19 NORTH PALM HARBOR, FL 34684 US Other 510(k) Applications for this Company
Contact	WILLIAM HARRIS 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	08/04/2000
Decision Date	12/04/2000
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