FDA 510(k) Application Details - K991097

Device Classification Name	Accessories, Catheter, G-U   More FDA Info for this Device
510(K) Number	K991097
Device Name	Accessories, Catheter, G-U
Applicant	MEDICAL DEVICE TECHNOLOGIES, INC. 3600 SW 47TH AVENUE GAINESVILLE, FL 32608 US Other 510(k) Applications for this Company
Contact	KARL SWARTZ Other 510(k) Applications for this Contact
Regulation Number	876.5130   More FDA Info for this Regulation Number
Classification Product Code	KNY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/01/1999
Decision Date	04/23/1999
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review