510(k) K913515
- Device
- TOTAL CONTAINMENT DEVICE
- Applicant
- DENCO
- 510(k) number
- K913515
- Product code
- KPF
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1994-05-26
- Date received
- 1991-08-07
- Regulation
- 876.5630
- Classification name
- System, Dialysate Delivery, Semi-automatic, Peritoneal
- Medical specialty
- Gastroenterology/Urology
- Review panel
- Gastroenterology/Urology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- SPENCER
- Address
- P.O. Box 9600 Wilmington DE US 19809 19809
FDA Registration Numbers#
- 1225714
- 1649518
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code KPF #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K061515 | RENALSOFT | Baxter Healthcare Corp | 2006-09-11 |
| K990953 | RENAL LINK | Baxter Healthcare Corp | 1999-06-18 |
| K970989 | CYBERREN | Cybernius Medical , Ltd. | 1997-07-24 |
| K955762 | PACKPD PERITONEAL DIALYSIS UREA KINETIC MODELING SOFTWARE PROGRAM | Fresenius USA, Inc. | 1996-07-31 |
| K875121 | AMICON EQUALINE FLUID BALANCE SYSTEM | Amicon, Inc. | 1988-02-19 |
| K874020 | ULTRACARE(TM) AUTOMATED PATIENT ASSIST DEVICE | Abbott Laboratories | 1988-01-29 |
| K821328 | C.A.P.D. AUTOMATIC HEATER #PDC 2000 HCP | Medionics International , Ltd. | 1982-07-28 |
| K802831 | GAMBRO PERITONEAL DIALYSIS MONITOR | Gambro, Inc. | 1980-12-18 |
| K800496 | CYCLER W/5 OR 10 HR. FILL/DWELL TIMER | American Medical Products, Inc. | 1980-07-21 |
| K791676 | PERITONEAL DIALYSIS CYCLER MODEL PDC1000 | J.M. Sounds Electronics Co. | 1979-12-06 |
| K791584 | CYLER/HEATER FOR PERITONEAL DIALYSIS | American Medical Products, Inc. | 1979-11-16 |
| K790091 | AMP AUTOMATIC CYCLER STAND | American Medical Products, Inc. | 1979-02-16 |
Legacy Summary#
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FDA Review#
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