The following data is part of a premarket notification filed by Medtronic Minimed with the FDA for Polyfin Qr Subcutaneous Infusion Set.
| Device ID | K954969 |
| 510k Number | K954969 |
| Device Name: | POLYFIN QR SUBCUTANEOUS INFUSION SET |
| 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 | 1995-10-30 |
| Decision Date | 1996-02-22 |