The following data is part of a premarket notification filed by Medtronic Minimed with the FDA for Medtronic Minimed Leapfrog Ii Infusion Set, Models Mmt-801s1, Mmt-801l1, Mmt-801s2, Mmt-801l2, Mmt-803s1.
| Device ID | K052431 |
| 510k Number | K052431 |
| Device Name: | MEDTRONIC MINIMED LEAPFROG II INFUSION SET, MODELS MMT-801S1, MMT-801L1, MMT-801S2, MMT-801L2, MMT-803S1 |
| Classification | Tubing, Fluid Delivery |
| Applicant | MEDTRONIC MINIMED 18000 DEVONSHIRE ST. Northridge, CA 91325 -1219 |
| Contact | Jodie Rogers |
| Correspondent | Jodie Rogers MEDTRONIC MINIMED 18000 DEVONSHIRE ST. Northridge, CA 91325 -1219 |
| Product Code | FPK |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-09-06 |
| Decision Date | 2005-11-29 |
| Summary: | summary |