FDA 510(k) Application Details - K963336

Device Classification Name	Catheter, Flow Directed   More FDA Info for this Device
510(K) Number	K963336
Device Name	Catheter, Flow Directed
Applicant	HARMAC MEDICAL PRODUCTS, INC. 2201 BAILEY AVE. BUFFALO, NY 14211-1797 US Other 510(k) Applications for this Company
Contact	JOSEPH KONIECZNY Other 510(k) Applications for this Contact
Regulation Number	870.1240   More FDA Info for this Regulation Number
Classification Product Code	DYG Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/28/1996
Decision Date	08/14/1997
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