FDA 510(k) Application Details - K013293

Device Classification Name	Needle, Hypodermic, Single Lumen   More FDA Info for this Device
510(K) Number	K013293
Device Name	Needle, Hypodermic, Single Lumen
Applicant	NIPRO MEDICAL CORP. 1384 COPPERFIELD COURT LEXINGTON, KY 40514-1268 US Other 510(k) Applications for this Company
Contact	KAELYN B HADLEY 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	10/02/2001
Decision Date	12/14/2001
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