FDA 510(k) Application Details - K101750

Device Classification Name	Strip, Dialysate Ph Indicator   More FDA Info for this Device
510(K) Number	K101750
Device Name	Strip, Dialysate Ph Indicator
Applicant	REPROCESSING PRODUCTS CORP. 8662 COMSTOCK LN. NORTH MAPLE GROVE, MN 55311 US Other 510(k) Applications for this Company
Contact	WALLY JANSEN Other 510(k) Applications for this Contact
Regulation Number	876.5820   More FDA Info for this Regulation Number
Classification Product Code	MNV Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/22/2010
Decision Date	01/07/2011
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