Peridial Peritoneal Dialysis Tray
FDA 510(k) K792207 · Cutter Laboratories, Inc.
510(k) numberK792207
Submission
- Device name
- Peridial Peritoneal Dialysis Tray
- Applicant
- Cutter Laboratories, Inc.
Mchenry, IL, US - Received
- November 2, 1979
- Decision date
- December 10, 1979
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- FKG – Tray, Start/Stop (Including Contents), Dialysis
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 876.5820
- Specialty
- Gastroenterology, Urology
Other 510(k)s with product code FKG
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K925469 | JJ Skinner Carekits(Tm) Dialysis On/Off KitFKG · Traditional | J.J. Skinner, Inc. | 05/03/1995SE |
| K871630 | Kits and Trays for Dialysis UseFKG · Traditional | Dove Medical Supplies | 05/26/1987SE |
| K833780 | Capd Prep KitFKG · Traditional | Professional Dialysis Products | 02/09/1984SE |
| K802361 | Dialyis Start Care KitFKG · Traditional | Med-Pak Corp. | 01/16/1981SE |
| K790353 | Acute Renal Dialysis TrayFKG · Traditional | Argon Medical Corp. | 04/20/1979SE |
More from Argon Medical Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K861315 | Hyperbaric Penetration Extension SetCBF · Traditional | 05/21/1986SE |
| K854106 | BaysilexELW · Traditional | 03/17/1986SE |
| K842324 | PerfourmELW · Traditional | 11/09/1984SE |
| K834106 | Intravenous Infusion ControllerLDR · Traditional | 05/30/1984SE |
| K832237 | Orthopedic Casting Tape MaxcastITG · Traditional | 08/16/1983SE |
| K823214 | Dosimetric Release Program - Admin. SetFPA · Traditional | 01/12/1983SE |
| K821326 | Cutter Bond Polycarboxylate CementEMA · Traditional | 05/28/1982SE |
| K813532 | Cutterbond Zinc Phosphate CementEMA · Traditional | 03/02/1982SE |
| K802105 | C-BladeHWE · Traditional | 09/16/1980SE |
| K802104 | C-SplintIQI · Traditional | 09/16/1980SE |
Questions and answers
When was Peridial Peritoneal Dialysis Tray cleared by the FDA?
Peridial Peritoneal Dialysis Tray (K792207) received a 510(k) decision of Substantially Equivalent on December 10, 1979, 38 days after the submission was received.
What is the product code of K792207?
The FDA product code is FKG – Tray, Start/Stop (Including Contents), Dialysis, a Class I (low risk) device regulated under 21 CFR 876.5820.