The following data is part of a premarket notification filed by Medtronic Minimed with the FDA for Modified Minimed Mdl404-sp/504-s Drug Insulin Pump.
| Device ID | K890457 |
| 510k Number | K890457 |
| Device Name: | MODIFIED MINIMED MDL404-SP/504-S DRUG INSULIN PUMP |
| Classification | Pump, Infusion |
| Applicant | MEDTRONIC MINIMED 12744 SAN FERNANDO RD. Sylmar, CA 91342 |
| Contact | William H Duffell |
| Correspondent | William H Duffell MEDTRONIC MINIMED 12744 SAN FERNANDO RD. Sylmar, CA 91342 |
| Product Code | FRN |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-01-30 |
| Decision Date | 1989-03-08 |