FDA 510(k) Application Details - K980193

Device Classification Name	Catheter, Nephrostomy   More FDA Info for this Device
510(K) Number	K980193
Device Name	Catheter, Nephrostomy
Applicant	MEDICAL DEVICE TECHNOLOGIES, INC. 4445 SW 35TH TERRACE SUITE 310 GAINESVILLE, FL 32608 US Other 510(k) Applications for this Company
Contact	KARL SWARTZ Other 510(k) Applications for this Contact
Regulation Number	000.0000   More FDA Info for this Regulation Number
Classification Product Code	LJE Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/20/1998
Decision Date	05/27/1998
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	-
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review