FDA 510(k) Application Details - K023591

Device Classification Name	Catheter, Intravascular, Diagnostic   More FDA Info for this Device
510(K) Number	K023591
Device Name	Catheter, Intravascular, Diagnostic
Applicant	DEROYAL INDUSTRIES, INC. 200 DEBUSK LN. POWELL, TN 37849 US Other 510(k) Applications for this Company
Contact	GRACIE GREENWAY Other 510(k) Applications for this Contact
Regulation Number	870.1200   More FDA Info for this Regulation Number
Classification Product Code	DQO Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/25/2002
Decision Date	06/18/2003
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