FDA 510(k) Application Details - K964968

Device Classification Name	Set, Administration, Intravascular   More FDA Info for this Device
510(K) Number	K964968
Device Name	Set, Administration, Intravascular
Applicant	UNIVERSITY OF MICHIGAN 1500 EAST, MEDICAL CENTER DR. ANN ARBOR,, MI 48109-0340 US Other 510(k) Applications for this Company
Contact	MARTIN R PRINCE, MD, PH.D. Other 510(k) Applications for this Contact
Regulation Number	880.5440   More FDA Info for this Regulation Number
Classification Product Code	FPA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/12/1996
Decision Date	02/27/1997
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