FDA 510(k) Application Details - K062387

Device Classification Name	More FDA Info for this Device
510(K) Number	K062387
Device Name	SMALL PERIPHERAL CUTTING BALLON, MONORAIL DELIVERY SYSTEM
Applicant	BOSTON SCIENTIFIC ONE SCIMED PLACE MAPLE GROVE, MN 55311 US Other 510(k) Applications for this Company
Contact	ANGIE BYLAND Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PNO Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/15/2006
Decision Date	10/05/2006
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