Panels › Gastroenterology, Urology › Product code FKG · Class 1
Tray, Start/Stop (Including Contents), Dialysis
Regulation 876.5820
0510(k)s in 12 months (6 all time)
1recalls in 12 months (11 all time)
0recalls that name a 510(k)
Top companies in FKG
| Company | 510(k)s | Recalls |
|---|---|---|
| MEDLINE INDUSTRIES, LP - Northfield | 0 | 5 |
| Centurion Medical Products | 0 | 3 |
| Lee Medical International Inc | 0 | 2 |
| Argon Medical Corp. | 1 | 0 |
| Cutter Laboratories, Inc. | 1 | 0 |
| Dove Medical Supplies | 1 | 0 |
| J.J. Skinner, Inc. | 1 | 0 |
| Med-Pak Corp. | 1 | 0 |
| Medline Industries, LP | 0 | 1 |
| Professional Dialysis Products | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| May 3, 1995 | K925469 | JJ SKINNER CAREKITS(TM) DIALYSIS ON/OFF KIT J.J. Skinner, Inc. | FKG |
| May 26, 1987 | K871630 | KITS AND TRAYS FOR DIALYSIS USE Dove Medical Supplies | FKG |
| Feb 9, 1984 | K833780 | CAPD PREP KIT Professional Dialysis Products | FKG |
| Jan 16, 1981 | K802361 | DIALYIS START CARE KIT Med-Pak Corp. | FKG |
| Dec 10, 1979 | K792207 | PERIDIAL PERITONEAL DIALYSIS TRAY Cutter Laboratories, Inc. | FKG |
| Apr 20, 1979 | K790353 | ACUTE RENAL DIALYSIS TRAY Argon Medical Corp. | FKG |
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