FDA 510(k) Application Details - K061194

Device Classification Name	Syringe, Antistick   More FDA Info for this Device
510(K) Number	K061194
Device Name	Syringe, Antistick
Applicant	SMITHS MEDICAL ASD, INC. 10 BOWMAN DR. KEENE, NH 03431 US Other 510(k) Applications for this Company
Contact	BRIAN FARIAS 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	04/28/2006
Decision Date	08/24/2006
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Abbreviated
Reviewed By Third Party	N
Expedited Review