FDA 510(k) Application Details - K974515

Device Classification Name	Electrode, Electrosurgical, Active, Urological   More FDA Info for this Device
510(K) Number	K974515
Device Name	Electrode, Electrosurgical, Active, Urological
Applicant	ENDOLAP, INC. 3012 MERCY DR. ORLANDO, FL 32808 US Other 510(k) Applications for this Company
Contact	TONY GILSTRAP Other 510(k) Applications for this Contact
Regulation Number	876.4300   More FDA Info for this Regulation Number
Classification Product Code	FAS Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/02/1997
Decision Date	12/22/1997
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review