FDA 510(k) Application Details - K981464

Device Classification Name	Coagulator-Cutter, Endoscopic, Unipolar (And Accessories)   More FDA Info for this Device
510(K) Number	K981464
Device Name	Coagulator-Cutter, Endoscopic, Unipolar (And Accessories)
Applicant	OMNITECH SYSTEMS, INC. 456 SOUTH CAMBELL, BLDG. C VALPARAISO, IN 46385 US Other 510(k) Applications for this Company
Contact	JON D BARRETT 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	04/23/1998
Decision Date	07/10/1998
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OB - Obstetrics/Gynecology
Review Advisory Committee	OB - Obstetrics/Gynecology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review