FDA 510(k) Application Details - K981061

Device Classification Name	Dilator, Catheter   More FDA Info for this Device
510(K) Number	K981061
Device Name	Dilator, Catheter
Applicant	MED INSTITUTE, INC. P.O. BOX 2402 WEST LAFAYETTE, IN 47906 US Other 510(k) Applications for this Company
Contact	NEAL FEARNOT Other 510(k) Applications for this Contact
Regulation Number	878.4200   More FDA Info for this Regulation Number
Classification Product Code	GCC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/23/1998
Decision Date	05/26/1998
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review