FDA 510(k) Application Details - K974475

Device Classification Name	Port & Catheter, Implanted, Subcutaneous, Intravascular   More FDA Info for this Device
510(K) Number	K974475
Device Name	Port & Catheter, Implanted, Subcutaneous, Intravascular
Applicant	BIOCONTROL TECHNOLOGY, INC. 300 INDIAN SPRINGS RD. P.O. BOX 434 INDIANA, PA 15701 US Other 510(k) Applications for this Company
Contact	PATRICK J COOPER 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	11/26/1997
Decision Date	03/02/1998
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review