The following data is part of a premarket notification filed by Medtronic Minimed with the FDA for Sof-set Qr Infusion Sets, Models Mmt-115 And Mmt-116.
| Device ID | K942181 |
| 510k Number | K942181 |
| Device Name: | SOF-SET QR INFUSION SETS, MODELS MMT-115 AND MMT-116 |
| Classification | Set, Administration, Intravascular |
| Applicant | MEDTRONIC MINIMED 12744 SAN FERNANDO RD. Sylmar, CA 91342 |
| Contact | John Livingston |
| Correspondent | John Livingston 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 | 1994-05-04 |
| Decision Date | 1994-07-14 |