K890457 is an FDA 510(k) clearance for the MODIFIED MINIMED MDL404-SP/504-S DRUG INSULIN PUMP. This device is classified as a Pump, Infusion (Class II - Special Controls, product code FRN).
Submitted by Medtronic Minimed (Sylmar, US). The FDA issued a Cleared decision on March 8, 1989, 37 days after receiving the submission on January 30, 1989.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5725.
| 510(k) Number | K890457 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 30, 1989 |
| Decision Date | March 08, 1989 |
| Days to Decision | 37 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | — |
| Product Code | FRN — Pump, Infusion |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5725 |