FDA.reportPublic FDA data

510(k) K023011

Device
OSMONICS SOLUTION DELIVERY SYSTEM
Applicant
Osmonics Medical Systems
510(k) number
K023011
Product code
FIN
Decision
Substantially Equivalent (SESE)
Decision date
2003-06-26
Date received
2002-09-09
Regulation
876.5820
Classification name
Tank, Holding, Dialysis
Medical specialty
Gastroenterology, Urology
Review panel
Gastroenterology, Urology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Applicant Contact#

Contact
KRISTINE KALISZEWSKI
Address
7848 S. 202nd St. Kent WA US 98032 98032

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code FIN#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K140984TANGO3 WATER STORAGE TANK WITH OZONE DISINFECTION SYSTEMTango3, LLC2015-01-12
K141213AMERIWATER OZONE DISINFECTION SYSTEMAmeriwater2014-12-10
K112427BICARB MIXING AND DISTRIBUTION SYSTEMIsopure, Corp.2012-01-26
K093641TANGO3 WATER STORAGE TANK WITH OZONE DISINFECTION SYSTEMTango3, LLC2010-12-08
K060333DIALYSIS SERVICES, INC., TYPHOON BICARB MIXING AND DISTRIBUTION SYSTEMDialysis Services, Inc.2006-09-08
K051031AMERIWATER SOLUTION MIX AND DISTRIBUTION SYSTEM FOR HEMODIALYSISAmeriwater2006-01-06
K031502USFILTER BICARBONATE MIXING AND DISPENSING (BICARB) SYSTEMUsfilter2004-08-27
K033118BIPRO MODEL SDS-CB200Medical Solutions International2004-06-28
K030366BICARD MIXING SYSTEMDialysis Systems, Inc.2004-04-19
K003560MAR COR SERVICES BICARB SYSTEMMar Cor Services, Inc.2001-06-08
K993272PURE WATER, INC.'S BICARB MIX, STORAGE AND DISTRIBUTION SYSTEMPure Water, Inc.2000-04-10
K993058PURE WATER INC'S ACIDIFIED STORAGE AND DISTRIBUTION SYSTEM WITH OPTIONAL REMOTE FILLPure Water, Inc.2000-01-24
K992793SODIUM BICARBONATE MIXING/DELIVERY SYSTEM, AND THE CONCENTRATE DELIVERY SYSTEMBetter Water, Inc.1999-11-16
K970674G.E.M. WATER SYSTEMS, INTERNATIONALG.E.M. Water Systems1997-11-19
K961416DIALYSIS MIXING & HOLDING TANKDial Medical Supply1996-08-21