FDA 510(k) Application Details - K082110

Device Classification Name	Stopcock, I.V. Set   More FDA Info for this Device
510(K) Number	K082110
Device Name	Stopcock, I.V. Set
Applicant	SURGIN SURGICAL INSTRUMENTATION, INC. 3722 AVE. SAUSALITO IRVINE, CA 92606 US Other 510(k) Applications for this Company
Contact	GRACE HOLLAND 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	07/28/2008
Decision Date	06/17/2009
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	N
Expedited Review