FDA 510(k) Application Details - K042504

Device Classification Name	Catheter,Intravascular,Therapeutic,Short-Term Less Than 30 Days   More FDA Info for this Device
510(K) Number	K042504
Device Name	Catheter,Intravascular,Therapeutic,Short-Term Less Than 30 Days
Applicant	MYCO MEDICAL SUPPLIES, INC. 113 CENTRE WEST COURT CARY, NC 27513 US Other 510(k) Applications for this Company
Contact	SANJIV KUMAR Other 510(k) Applications for this Contact
Regulation Number	880.5200   More FDA Info for this Regulation Number
Classification Product Code	FOZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/15/2004
Decision Date	01/19/2006
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review