RP-510/RP-514 Parallel Plate Dialyzers
FDA 510(k) K780427 · Hospal Medical Corp.
510(k) numberK780427
Submission
- Device name
- RP-510/RP-514 Parallel Plate Dialyzers
- Applicant
- Hospal Medical Corp.
Mchenry, IL, US - Received
- March 17, 1978
- Decision date
- May 19, 1978
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- FJG – Dialyzer, Parallel Flow
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5820
- Specialty
- Gastroenterology, Urology
- Life-sustaining
- Yes
Other 510(k)s with product code FJG
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K933681 | Gambro Lundia Pro 100, 500, 600 DialyzersFJG · Traditional | Cobe Renal Care, Inc. | 09/07/1994SE |
| K933680 | Gambro Lundia Pro 200 DialyzerFJG · Traditional | Cobe Renal Care, Inc. | 08/26/1994SE |
| K920693 | Dextrolyte II Peritoneal Dialysis 48-3028-9FJG · Traditional | National Medical Care, Medical Products Div., Inc. | 09/21/1992SE |
| K915504 | Gambro Lundia Alpha HemodialyzersFJG · Traditional | C.G.H. Medical, Inc. | 03/06/1992SE |
| K901368 | Hemospal Kits A1, A2D, Ao, & A1DFJG · Traditional | Gambro-Hospal, Inc. | 08/02/1990SE |
| K902203 | Tenckhoff Peritoneal Dialysis KitFJG · Traditional | Akcess Medical Products, Inc. | 08/01/1990SESK |
| K862840 | Gambro Lundia 10-1L, 1N, 1H, 3H, 4N, 4H, 5H, 6NFJG · Traditional | Gambro, Inc. | 09/29/1986SE |
| K853406 | Gambro Lundia Pro 3 & 5 DialyzerFJG · Traditional | Gambro, Inc. | 01/08/1986SE |
| K820694 | Cobe PPD 1.3L, #18-520-009FJG · Traditional | Cobe Laboratories, Inc. | 03/31/1982SE |
| K812336 | Cobe PPD 1.9FJG · Traditional | Cobe Laboratories, Inc. | 08/31/1981SE |
More from Cobe Laboratories, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K893742 | Filtral TM 20 Hemodialyzer/FilterKDI · Traditional | 07/24/1989SE |
| K884365 | Multiflow(Tm) 60 KitKDI · Traditional | 12/08/1988SE |
| K884326 | Filtral TM 8 HemodialyzerKDI · Traditional | 12/05/1988SE |
| K883307 | Cardioflow 100 Hemoconcentrator/Preparation KitKDI · Traditional | 10/12/1988SE |
| K872767 | Filtral 10, Filtral 12, Filtral 16 HemodialyzerKDI · Traditional | 12/29/1987SE |
| K871218 | Monitral S GS Hemodialysis Single Patient UnitFKP · Traditional | 04/30/1987SE |
| K863961 | Hospal Biospal 1800SKDI · Traditional | 12/17/1986SE |
| K863592 | Disscap 80E, 110E, 140E, 160EFJI · Traditional | 09/25/1986SE |
| K861156 | Hospal Dialysate for CavhdKPO · Traditional | 09/23/1986SE |
| K861230 | Monitral SFKP · Traditional | 04/25/1986SE |
Questions and answers
When was RP-510/RP-514 Parallel Plate Dialyzers cleared by the FDA?
RP-510/RP-514 Parallel Plate Dialyzers (K780427) received a 510(k) decision of Substantially Equivalent on May 19, 1978, 63 days after the submission was received.
What is the product code of K780427?
The FDA product code is FJG – Dialyzer, Parallel Flow, a Class II (moderate risk) device regulated under 21 CFR 876.5820.