FDA 510(k) Application Details - K993058

Device Classification Name	Tank, Holding, Dialysis   More FDA Info for this Device
510(K) Number	K993058
Device Name	Tank, Holding, Dialysis
Applicant	PURE WATER, INC. 305 WEST MARKET ST. ANDERSON, SC 29624 US Other 510(k) Applications for this Company
Contact	RHONDA S MCCOY Other 510(k) Applications for this Contact
Regulation Number	876.5820   More FDA Info for this Regulation Number
Classification Product Code	FIN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/13/1999
Decision Date	01/24/2000
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