FDA 510(k) Application Details - K102409

Device Classification Name	Endoscope Channel Accessory   More FDA Info for this Device
510(K) Number	K102409
Device Name	Endoscope Channel Accessory
Applicant	BYRNE MEDICAL INC. 3150 POLLOK DR CONROE, TX 77303 US Other 510(k) Applications for this Company
Contact	JOHN WILLIS 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	08/24/2010
Decision Date	11/04/2010
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