FDA 510(k) Application Details - K003405

Device Classification Name	Coagulator-Cutter, Endoscopic, Unipolar (And Accessories)   More FDA Info for this Device
510(K) Number	K003405
Device Name	Coagulator-Cutter, Endoscopic, Unipolar (And Accessories)
Applicant	HIGHLAND / MARIETTA, INC. 6155 HEISLEY RD. MENTOR, OH 44060 US Other 510(k) Applications for this Company
Contact	JOHN NIKSA Other 510(k) Applications for this Contact
Regulation Number	884.4160   More FDA Info for this Regulation Number
Classification Product Code	KNF Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/01/2000
Decision Date	05/07/2001
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OB - Obstetrics/Gynecology
Review Advisory Committee	OB - Obstetrics/Gynecology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review