FDA 510(k) Application Details - K003569

Device Classification Name	Unit, Electrosurgical, Endoscopic (With Or Without Accessories)   More FDA Info for this Device
510(K) Number	K003569
Device Name	Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
Applicant	GYRUS MEDICAL LTD. FORTRAN RD., ST. MELLONS CARDIFF CF3 0LT GB Other 510(k) Applications for this Company
Contact	DAVID KAY Other 510(k) Applications for this Contact
Regulation Number	876.4300   More FDA Info for this Regulation Number
Classification Product Code	KNS Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/20/2000
Decision Date	12/19/2000
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review