FDA 510(k) Application Details - K043419

Device Classification Name	Syringe, Antistick   More FDA Info for this Device
510(K) Number	K043419
Device Name	Syringe, Antistick
Applicant	MEDEXEL MEDICAL MFG. CO., LTD. PO BOX 7007 DEERFIELD, IL 60015 US Other 510(k) Applications for this Company
Contact	DANIEL KAMM Other 510(k) Applications for this Contact
Regulation Number	880.5860   More FDA Info for this Regulation Number
Classification Product Code	MEG Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/13/2004
Decision Date	04/15/2005
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