FDA 510(k) Application Details - K080780

Device Classification Name	Cystourethroscope   More FDA Info for this Device
510(K) Number	K080780
Device Name	Cystourethroscope
Applicant	EPITEK, INC. 4801 W. 81ST STREET SUITE 105 BLOOMINGTON, MN 55437 US Other 510(k) Applications for this Company
Contact	WERNER HAMPL Other 510(k) Applications for this Contact
Regulation Number	876.1500   More FDA Info for this Regulation Number
Classification Product Code	FBO Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/19/2008
Decision Date	07/30/2008
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