FDA 510(k) Application Details - K123805

Device Classification Name	Detector, Leak, Blood   More FDA Info for this Device
510(K) Number	K123805
Device Name	Detector, Leak, Blood
Applicant	REPROCESSING PRODUCTS CORP. P.O. BOX 35849 TUCSON, AZ 85740 US Other 510(k) Applications for this Company
Contact	TED WILLIAMS Other 510(k) Applications for this Contact
Regulation Number	876.5820   More FDA Info for this Regulation Number
Classification Product Code	FJD Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/11/2012
Decision Date	03/20/2013
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