K010712 is an FDA 510(k) clearance for the DIALYSATE LINE WITH CONNECTORS/RE-USE WASH-OUT LINES, 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 27, 2001, 202 days after receiving the submission on March 9, 2001. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5820.
| 510(k) Number | K010712 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | March 09, 2001 |
| Decision Date | September 27, 2001 |
| Days to Decision | 202 days |
| Submission Type | Abbreviated |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Statement |
| Product Code | FID — Tubing, Dialysate |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 876.5820 |