FDA 510(k) Application Details - K092118

Device Classification Name	Catheter, Intravascular, Diagnostic   More FDA Info for this Device
510(K) Number	K092118
Device Name	Catheter, Intravascular, Diagnostic
Applicant	Oscor Inc. 3816 DE SOTO BLVD. PALM HARBOR, FL 34683 US Other 510(k) Applications for this Company
Contact	MILA DOSKOCIL 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	07/14/2009
Decision Date	01/13/2010
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