FDA 510(k) Application Details - K003972

Device Classification Name	Catheter, Angioplasty, Peripheral, Transluminal   More FDA Info for this Device
510(K) Number	K003972
Device Name	Catheter, Angioplasty, Peripheral, Transluminal
Applicant	NUMED, INC. 2880 MAIN ST. HOPKINTON, NY 12965 US Other 510(k) Applications for this Company
Contact	NICHELL LAFLESH Other 510(k) Applications for this Contact
Regulation Number	870.1250   More FDA Info for this Regulation Number
Classification Product Code	LIT Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/22/2000
Decision Date	01/11/2001
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review