FDA 510(k) Application Details - K060971

Device Classification Name	Syringe, Antistick   More FDA Info for this Device
510(K) Number	K060971
Device Name	Syringe, Antistick
Applicant	OMI MANUFACTURING PTY., 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	04/07/2006
Decision Date	10/24/2006
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