FDA 510(k) Application Details - K070856

Device Classification Name	Syringe, Piston   More FDA Info for this Device
510(K) Number	K070856
Device Name	Syringe, Piston
Applicant	ICU MEDICAL, INC 4455 ATHERTON DR. SALT LAKE CITY, UT 84123 US Other 510(k) Applications for this Company
Contact	TRACY S BEST Other 510(k) Applications for this Contact
Regulation Number	880.5860   More FDA Info for this Regulation Number
Classification Product Code	FMF Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/28/2007
Decision Date	10/05/2007
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