K934069 is an FDA 510(k) clearance for the MILLEX, DUALEX (PLUS, ULTRA), a Protector, Transducer, Dialysis (Class II — Special Controls, product code FIB), submitted by Millipore Corp. (Bedford, US). The FDA issued a Cleared decision on April 21, 1994, 244 days after receiving the submission on August 20, 1993. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5820.
| 510(k) Number | K934069 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | August 20, 1993 |
| Decision Date | April 21, 1994 |
| Days to Decision | 244 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Statement |
| Product Code | FIB — Protector, Transducer, Dialysis |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 876.5820 |