The following data is part of a premarket notification filed by Novo Nordisk Pharmaceuticals, Inc. with the FDA for Novopen 1.5.
| Device ID | K942159 |
| 510k Number | K942159 |
| Device Name: | NOVOPEN 1.5 |
| Classification | Syringe, Piston |
| Applicant | NOVO NORDISK PHARMACEUTICALS, INC. 100 OVERLOOK CTR. Princeton, NJ 08540 -7810 |
| Contact | George A Clay, Ph.d |
| Correspondent | George A Clay, Ph.d 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 | 1994-05-03 |
| Decision Date | 1995-04-26 |