510(k) K993058
- Device
- PURE WATER INC'S ACIDIFIED STORAGE AND DISTRIBUTION SYSTEM WITH OPTIONAL REMOTE FILL
- Applicant
- PURE WATER, INC.
- 510(k) number
- K993058
- Product code
- FIN
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2000-01-24
- Date received
- 1999-09-13
- 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
- No
Applicant Contact#
- Contact
- RHONDA S MCCOY
- Address
- 305 W. Market St. Anderson SC US 29624 29624
FDA Registration Numbers#
- 3005021818
- 1055109
- 3019131
- 1530185
- 3003768032
Source Documents#
Other 510(k) Records For Product Code FIN #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K140984 | TANGO3 WATER STORAGE TANK WITH OZONE DISINFECTION SYSTEM | Tango3, LLC | 2015-01-12 |
| K141213 | AMERIWATER OZONE DISINFECTION SYSTEM | Ameriwater | 2014-12-10 |
| K112427 | BICARB MIXING AND DISTRIBUTION SYSTEM | Isopure, Corp. | 2012-01-26 |
| K093641 | TANGO3 WATER STORAGE TANK WITH OZONE DISINFECTION SYSTEM | Tango3, LLC | 2010-12-08 |
| K060333 | DIALYSIS SERVICES, INC., TYPHOON BICARB MIXING AND DISTRIBUTION SYSTEM | Dialysis Services, Inc. | 2006-09-08 |
| K051031 | AMERIWATER SOLUTION MIX AND DISTRIBUTION SYSTEM FOR HEMODIALYSIS | Ameriwater | 2006-01-06 |
| K031502 | USFILTER BICARBONATE MIXING AND DISPENSING (BICARB) SYSTEM | Usfilter | 2004-08-27 |
| K033118 | BIPRO MODEL SDS-CB200 | Medical Solutions International | 2004-06-28 |
| K030366 | BICARD MIXING SYSTEM | Dialysis Systems, Inc. | 2004-04-19 |
| K023011 | OSMONICS SOLUTION DELIVERY SYSTEM | Osmonics Medical Systems | 2003-06-26 |
| K003560 | MAR COR SERVICES BICARB SYSTEM | Mar Cor Services, Inc. | 2001-06-08 |
| K993272 | PURE WATER, INC.'S BICARB MIX, STORAGE AND DISTRIBUTION SYSTEM | Pure Water, Inc. | 2000-04-10 |
| K992793 | SODIUM BICARBONATE MIXING/DELIVERY SYSTEM, AND THE CONCENTRATE DELIVERY SYSTEM | Better Water, Inc. | 1999-11-16 |
| K970674 | G.E.M. WATER SYSTEMS, INTERNATIONAL | G.E.M. Water Systems | 1997-11-19 |
| K961416 | DIALYSIS MIXING & HOLDING TANK | Dial Medical Supply | 1996-08-21 |
Legacy Summary#
summary
FDA Review#
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