FDA 510(k) Application Details - K991426

Device Classification Name	Resectoscope, Working Element   More FDA Info for this Device
510(K) Number	K991426
Device Name	Resectoscope, Working Element
Applicant	MAHE INTL., INC. 300 JAMES ROBERTSON PKWY. NASHVILLE, TN 37201 US Other 510(k) Applications for this Company
Contact	WINIFRIED REICH Other 510(k) Applications for this Contact
Regulation Number	876.1500   More FDA Info for this Regulation Number
Classification Product Code	FDC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/23/1999
Decision Date	08/05/1999
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