FDA 510(k) Application Details - K970690

Device Classification Name	Wire, Guide, Catheter   More FDA Info for this Device
510(K) Number	K970690
Device Name	Wire, Guide, Catheter
Applicant	COOK PACEMAKER CORP. RT. 66, RIVER RD. P.O. BOX 529 LEECHBURG, PA 15656 US Other 510(k) Applications for this Company
Contact	NEAL E FEANOT, PH.D.;E.E. 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	02/25/1997
Decision Date	05/20/1997
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review