The following data is part of a premarket notification filed by Medtronic Minimed with the FDA for Model 404-sp And 504-sp Infusion Pumps Modified.
| Device ID | K912458 |
| 510k Number | K912458 |
| Device Name: | MODEL 404-SP AND 504-SP INFUSION PUMPS MODIFIED |
| Classification | Pump, Infusion |
| Applicant | MEDTRONIC MINIMED 12744 SAN FERNANDO RD. Sylmar, CA 91342 |
| Contact | Cynthia L Luchetti |
| Correspondent | Cynthia L Luchetti 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 | 1991-05-24 |
| Decision Date | 1991-06-24 |