FDA 510(k) Application Details - K101017

Device Classification Name	Port & Catheter, Implanted, Subcutaneous, Intravascular   More FDA Info for this Device
510(K) Number	K101017
Device Name	Port & Catheter, Implanted, Subcutaneous, Intravascular
Applicant	ANGIODYNAMICS, INC. 603 QUEENSBURY AVE. QUEENSBURY, NY 12804 US Other 510(k) Applications for this Company
Contact	S. MICHAEL SHARP Other 510(k) Applications for this Contact
Regulation Number	880.5965   More FDA Info for this Regulation Number
Classification Product Code	LJT Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/12/2010
Decision Date	06/17/2010
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Statement
Type	Special
Reviewed By Third Party	N
Expedited Review