FDA 510(k) Application Details - K043249

Device Classification Name	Needle, Hypodermic, Single Lumen   More FDA Info for this Device
510(K) Number	K043249
Device Name	Needle, Hypodermic, Single Lumen
Applicant	ATRION MEDICAL PRODUCTS, INC. 1426 CURT FRANCIS RD. PO BOX 564 ARAB, AL 35016 US Other 510(k) Applications for this Company
Contact	DAN CLARK 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	11/23/2004
Decision Date	05/25/2005
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