FDA 510(k) Application Details - K122767

Device Classification Name	Port & Catheter, Implanted, Subcutaneous, Intravascular   More FDA Info for this Device
510(K) Number	K122767
Device Name	Port & Catheter, Implanted, Subcutaneous, Intravascular
Applicant	NAVILYST MEDICAL, INC. 26 FOREST STREET MARLBOROUGH, MA 01752 US Other 510(k) Applications for this Company
Contact	Lorraine M Hanley 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	09/10/2012
Decision Date	04/30/2013
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Abbreviated
Reviewed By Third Party	N
Expedited Review