FDA 510(k) Application Details - K061032

Device Classification Name	Needle, Hypodermic, Single Lumen   More FDA Info for this Device
510(K) Number	K061032
Device Name	Needle, Hypodermic, Single Lumen
Applicant	IMPRINT PHARMACEUTICALS LIMITED 53 LANGTON ROAD EAST MOLESEY, SURREY KT8 2HX GB Other 510(k) Applications for this Company
Contact	MERVYN LITTLE 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	04/14/2006
Decision Date	06/21/2006
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Statement
Type	Special
Reviewed By Third Party	N
Expedited Review