FDA 510(k) Application Details - K052561

Device Classification Name	Needle, Hypodermic, Single Lumen   More FDA Info for this Device
510(K) Number	K052561
Device Name	Needle, Hypodermic, Single Lumen
Applicant	KOFU FACTORY OF TERUMO CORP. 1727-1 TSUIJIARAI, SHOWA-CHO NAKAKOMA-GUN, YAMANASHI 409-3853 JP Other 510(k) Applications for this Company
Contact	BARBARA SMITH 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	09/19/2005
Decision Date	11/23/2005
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