FDA 510(k) Application Details - K981936

Device Classification Name	Wire, Guide, Catheter   More FDA Info for this Device
510(K) Number	K981936
Device Name	Wire, Guide, Catheter
Applicant	ADVANCED BIOMEDICAL DEVICES, INC. 3 DUNDEE PARK ANDOVER, MA 01810 US Other 510(k) Applications for this Company
Contact	R. EDWARD WINTERS Other 510(k) Applications for this Contact
Regulation Number	870.1330   More FDA Info for this Regulation Number
Classification Product Code	DQX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/02/1998
Decision Date	02/16/2000
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review