The following data is part of a premarket notification filed by Molnlycke A/s Hospital Products with the FDA for Mesulin, Insulin Infusion Set.
| Device ID | K861250 |
| 510k Number | K861250 |
| Device Name: | MESULIN, INSULIN INFUSION SET |
| Classification | Set, Administration, Intravascular |
| Applicant | MOLNLYCKE A/S HOSPITAL PRODUCTS HOEJVANGEN 6, DK-3060 ESPERGAERDE Denmark, DK |
| Contact | Bente Lewinsky |
| Correspondent | Bente Lewinsky MOLNLYCKE A/S HOSPITAL PRODUCTS HOEJVANGEN 6, DK-3060 ESPERGAERDE Denmark, DK |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-04-02 |
| Decision Date | 1986-05-23 |