FDA 510(k) Application Details - K050857

Device Classification Name	Catheter, Angioplasty, Peripheral, Transluminal, Dual-Balloon   More FDA Info for this Device
510(K) Number	K050857
Device Name	Catheter, Angioplasty, Peripheral, Transluminal, Dual-Balloon
Applicant	NUMED, INC. 2880 MAIN ST. HOPKINTON, NY 12965 US Other 510(k) Applications for this Company
Contact	JODI GIJANTO Other 510(k) Applications for this Contact
Regulation Number	870.1250   More FDA Info for this Regulation Number
Classification Product Code	NVM Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/05/2005
Decision Date	07/28/2005
Decision	SESU - SE - WITH LIMITATIONS
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review