FDA 510(k) Application Details - K991404

Device Classification Name	Needle, Hypodermic, Single Lumen   More FDA Info for this Device
510(K) Number	K991404
Device Name	Needle, Hypodermic, Single Lumen
Applicant	ITL CORPORATION, PTY LTD. 15825 SHADY GROVE RD. SUITE 90 ROCKVILLE, MD 20850 US Other 510(k) Applications for this Company
Contact	KENNETH A PALMER Other 510(k) Applications for this Contact
Regulation Number	880.5570   More FDA Info for this Regulation Number
Classification Product Code	FMI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/22/1999
Decision Date	05/14/1999
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