FDA 510(k) Application Details - K090338

Device Classification Name	Strip, Test, Reagent, Residuals For Dialysate, Disinfectant   More FDA Info for this Device
510(K) Number	K090338
Device Name	Strip, Test, Reagent, Residuals For Dialysate, Disinfectant
Applicant	REPROCESSING PRODUCTS CORP. 8662 COMSTOCK LN. MAPLE GROVE, MN 55311 US Other 510(k) Applications for this Company
Contact	WALLY JANSEN Other 510(k) Applications for this Contact
Regulation Number	876.5665   More FDA Info for this Regulation Number
Classification Product Code	MSY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/10/2009
Decision Date	05/08/2009
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