FDA 510(k) Application Details - K080600

Device Classification Name	Syringe, Antistick   More FDA Info for this Device
510(K) Number	K080600
Device Name	Syringe, Antistick
Applicant	ULTIMED, INC. 5353 WAYZATA BLVD. SUITE 505 MINNEAPOLIS, MN 55416-1334 US Other 510(k) Applications for this Company
Contact	CAROLE STAMP 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	03/03/2008
Decision Date	06/25/2008
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