FDA 510(k) Application Details - K033373

Device Classification Name	Needle, Hypodermic, Single Lumen   More FDA Info for this Device
510(K) Number	K033373
Device Name	Needle, Hypodermic, Single Lumen
Applicant	TYCO HEALTHCARE 15 HAMPSHIRE ST. MANSFIELD, MA 02048 US Other 510(k) Applications for this Company
Contact	DAVID OLSON 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	10/22/2003
Decision Date	11/13/2003
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review