The following data is part of a premarket notification filed by Medtronic Minimed with the FDA for Polyfin Infusion Set, Models Mmt-165, Mmt-365, Mmt-366, Mmt-312s And Mmt-312l And Sof-set Infusion Sets.
| Device ID | K100432 |
| 510k Number | K100432 |
| Device Name: | POLYFIN INFUSION SET, MODELS MMT-165, MMT-365, MMT-366, MMT-312S AND MMT-312L AND SOF-SET INFUSION SETS |
| Classification | Set, Administration, Intravascular |
| Applicant | MEDTRONIC MINIMED 18000 DEVONSHIRE ST. Northridge, CA 91325 -1219 |
| Contact | Mark Faillace |
| Correspondent | Mark Faillace MEDTRONIC MINIMED 18000 DEVONSHIRE ST. Northridge, CA 91325 -1219 |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-02-16 |
| Decision Date | 2010-07-09 |