FDA 510(k) Application Details - K060866

Device Classification Name	Set, I.V. Fluid Transfer   More FDA Info for this Device
510(K) Number	K060866
Device Name	Set, I.V. Fluid Transfer
Applicant	CARMEL PHARMA AB. AMINOGATAN 30, MOLNDAL BOX 5352 GOTEBORG SE 402 28 SE Other 510(k) Applications for this Company
Contact	KJELL ANDREASSON Other 510(k) Applications for this Contact
Regulation Number	880.5440   More FDA Info for this Regulation Number
Classification Product Code	LHI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/30/2006
Decision Date	04/28/2006
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