FDA 510(k) Application Details - K971140

Device Classification Name	Port & Catheter, Implanted, Subcutaneous, Intravascular   More FDA Info for this Device
510(K) Number	K971140
Device Name	Port & Catheter, Implanted, Subcutaneous, Intravascular
Applicant	MED INSTITUTE, INC. P.O. BOX 2402 WEST LAFAYETTE, IN 47906 US Other 510(k) Applications for this Company
Contact	NEAL E FEARNOT 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	03/28/1997
Decision Date	11/17/1997
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