K022068 is an FDA 510(k) clearance for the TUBING, DIALYSATE (AND CONNECTOR), a Tubing, Dialysate (Class II — Special Controls, product code FID), submitted by Molded Products, Inc. (Harlan, US). The FDA issued a Cleared decision on September 23, 2002, 90 days after receiving the submission on June 25, 2002. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5820.
| 510(k) Number | K022068 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | June 25, 2002 |
| Decision Date | September 23, 2002 |
| Days to Decision | 90 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Statement |
| Product Code | FID — Tubing, Dialysate |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 876.5820 |