FDA 510(k) Application Details - K970945

Device Classification Name	Unit, Electrosurgical, Endoscopic (With Or Without Accessories)   More FDA Info for this Device
510(K) Number	K970945
Device Name	Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
Applicant	UNITED STATES ENDOSCOPY GROUP, INC. 9330 PROGRESS PKWY. MENTOR, OH 44060 US Other 510(k) Applications for this Company
Contact	GRETCHEN YOUNKER-COHEN 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	03/14/1997
Decision Date	05/07/1997
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