FDA 510(k) Application Details - K052330

Device Classification Name	Stopcock, I.V. Set   More FDA Info for this Device
510(K) Number	K052330
Device Name	Stopcock, I.V. Set
Applicant	MEDEGEN MEDICAL MANUFACTURING SERVICES 930 WANAMAKER AVE. ONTARIO, CA 91761 US Other 510(k) Applications for this Company
Contact	TIM TRUITT 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	08/26/2005
Decision Date	09/09/2005
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	Y
Expedited Review