FDA 510(k) Application Details - K971066

Device Classification Name	Set, Administration, Intravascular   More FDA Info for this Device
510(K) Number	K971066
Device Name	Set, Administration, Intravascular
Applicant	TAMARYN MEDICAL SYSTEMS, INC. 6539 SOUTH 2475 EAST SALT LAKE CITY, UT 84121 US Other 510(k) Applications for this Company
Contact	JIM KEANE 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	03/24/1997
Decision Date	06/04/1997
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