FDA 510(k) Application Details - K964439

Device Classification Name	Set, Administration, Intravascular   More FDA Info for this Device
510(K) Number	K964439
Device Name	Set, Administration, Intravascular
Applicant	BMW MEDICAL, INC. 3598 WEST 1820 SOUTH SALT LAKE CITY, UT 84104-4959 US Other 510(k) Applications for this Company
Contact	ROGER L RICHINS 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	11/06/1996
Decision Date	07/16/1997
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review