FDA 510(k) Application Details - K082836

Device Classification Name	Stopcock, I.V. Set   More FDA Info for this Device
510(K) Number	K082836
Device Name	Stopcock, I.V. Set
Applicant	ICU MEDICAL, INC. 4455 ATHERTON DRIVE SALT LAKE CITY, UT 84123 US Other 510(k) Applications for this Company
Contact	NILOUFAR SAMIMI Other 510(k) Applications for this Contact
Regulation Number	880.5440   More FDA Info for this Regulation Number
Classification Product Code	FMG Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/26/2008
Decision Date	02/25/2009
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review