The following data is part of a premarket notification filed by Medtronic Minimed with the FDA for Modification To Medtronic Minimed Paradigm Model 512 Insulin Pump.
| Device ID | K041317 |
| 510k Number | K041317 |
| Device Name: | MODIFICATION TO MEDTRONIC MINIMED PARADIGM MODEL 512 INSULIN PUMP |
| Classification | Pump, Infusion, Insulin |
| Applicant | MEDTRONIC MINIMED 18000 DEVONSHIRE ST. Northridge, CA 91325 -1219 |
| Contact | Mark J Faillace |
| Correspondent | Mark J Faillace MEDTRONIC MINIMED 18000 DEVONSHIRE ST. Northridge, CA 91325 -1219 |
| Product Code | LZG |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-05-18 |
| Decision Date | 2004-07-19 |