FKG — Tray, Start/Stop (Including Contents), Dialysis Class I
FDA product code FKG covers "Tray, Start/Stop (Including Contents), Dialysis", a Class I medical device regulated under 21 CFR 876.5820. Submissions are reviewed by the Gastroenterology, Urology panel. At least 6 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- FKG
- Device Class
- Class I
- Regulation Number
- 876.5820
- Submission Type
- Review Panel
- GU
- Medical Specialty
- Gastroenterology, Urology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K925469 | j.j. skinner | JJ SKINNER CAREKITS(TM) DIALYSIS ON/OFF KIT | May 3, 1995 |
| K871630 | dove medical supplies | KITS AND TRAYS FOR DIALYSIS USE | May 26, 1987 |
| K833780 | professional dialysis products | CAPD PREP KIT | February 9, 1984 |
| K802361 | med-pak | DIALYIS START CARE KIT | January 16, 1981 |
| K792207 | cutter laboratories | PERIDIAL PERITONEAL DIALYSIS TRAY | December 10, 1979 |
| K790353 | argon medical | ACUTE RENAL DIALYSIS TRAY | April 20, 1979 |