FDA 510(k) Application Details - K971844

Device Classification Name	Set, Administration, Intravascular   More FDA Info for this Device
510(K) Number	K971844
Device Name	Set, Administration, Intravascular
Applicant	MCKINLEY, INC. 4080 YOUNGFIELD ST. WHEAT RIDGE, CO 80033 US Other 510(k) Applications for this Company
Contact	BRIAN D ZDEB 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	05/19/1997
Decision Date	01/23/1998
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