The following data is part of a premarket notification filed by Medtronic Minimed with the FDA for Polyfin Infusion Set Mmt-106/mmt-107/mmt-133.
| Device ID | K961474 |
| 510k Number | K961474 |
| Device Name: | POLYFIN INFUSION SET MMT-106/MMT-107/MMT-133 |
| Classification | Set, Administration, Intravascular |
| Applicant | MEDTRONIC MINIMED 12744 SAN FERNANDO RD. Sylmar, CA 91342 |
| Contact | Terrance H Gregg |
| Correspondent | Terrance H Gregg MEDTRONIC MINIMED 12744 SAN FERNANDO RD. Sylmar, CA 91342 |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-04-18 |
| Decision Date | 1996-05-06 |
| Summary: | summary |