FDA 510(k) Application Details - K073507

Device Classification Name	Endoscope Channel Accessory   More FDA Info for this Device
510(K) Number	K073507
Device Name	Endoscope Channel Accessory
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	ODC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/13/2007
Decision Date	03/05/2008
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