The following data is part of a premarket notification filed by Medtronic Minimed with the FDA for Polyfin Qr With Wings Infusion Sets, Models 365, 366, And 367.
| Device ID | K964456 |
| 510k Number | K964456 |
| Device Name: | POLYFIN QR WITH WINGS INFUSION SETS, MODELS 365, 366, AND 367 |
| Classification | Set, Administration, Intravascular |
| Applicant | MEDTRONIC MINIMED 12744 SAN FERNANDO RD. Sylmar, CA 91342 |
| Contact | Don Selvey |
| Correspondent | Don Selvey 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 | 1996-11-06 |
| Decision Date | 1997-01-30 |
| Summary: | summary |