FDA 510(k) Application Details - K971881

Device Classification Name	Resectoscope   More FDA Info for this Device
510(K) Number	K971881
Device Name	Resectoscope
Applicant	COMEG ENDOSCOPY 13790 EAST RICE PLACE AURORA, CO 80015 US Other 510(k) Applications for this Company
Contact	KAELYN HADLEY Other 510(k) Applications for this Contact
Regulation Number	876.1500   More FDA Info for this Regulation Number
Classification Product Code	FJL Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/20/1997
Decision Date	08/12/1997
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