K010366 is an FDA 510(k) clearance for the DISPOSABLE STORAGE CAP, a Dialyzer, Capillary, Hollow Fiber (Class II — Special Controls, product code FJI), submitted by Molded Products, Inc. (Harlan, US). The FDA issued a Cleared decision on November 28, 2001, 294 days after receiving the submission on February 7, 2001. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5820.
| 510(k) Number | K010366 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | February 07, 2001 |
| Decision Date | November 28, 2001 |
| Days to Decision | 294 days |
| Submission Type | Abbreviated |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Statement |
| Product Code | FJI — Dialyzer, Capillary, Hollow Fiber |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 876.5820 |