The following data is part of a premarket notification filed by Novo Nordisk Pharmaceuticals, Inc. with the FDA for Novolinpen Dial-a-dose Insulin Delivery Device.
| Device ID | K921908 |
| 510k Number | K921908 |
| Device Name: | NOVOLINPEN DIAL-A-DOSE INSULIN DELIVERY DEVICE |
| Classification | Syringe, Piston |
| Applicant | NOVO NORDISK PHARMACEUTICALS, INC. 100 OVERLOOK CTR. Princeton, NJ 08540 -7810 |
| Contact | Nathan H Block |
| Correspondent | Nathan H Block NOVO NORDISK PHARMACEUTICALS, INC. 100 OVERLOOK CTR. Princeton, NJ 08540 -7810 |
| Product Code | FMF |
| CFR Regulation Number | 880.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-04-23 |
| Decision Date | 1993-06-29 |