FDA 510(k) Application Details - K000825

Device Classification Name	Catheter, Intravascular, Diagnostic   More FDA Info for this Device
510(K) Number	K000825
Device Name	Catheter, Intravascular, Diagnostic
Applicant	MEDI-DYNE, INC. 604 QUEENSBURY AVE. QUEENSBURY, NY 12804 US Other 510(k) Applications for this Company
Contact	NORMAN HALL 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	03/14/2000
Decision Date	09/21/2000
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