The following data is part of a premarket notification filed by Nordisk Infuser System with the FDA for Nordisk Infuser System With Pre-filled Cartridge.
| Device ID | K860492 |
| 510k Number | K860492 |
| Device Name: | NORDISK INFUSER SYSTEM WITH PRE-FILLED CARTRIDGE |
| Classification | Pump, Infusion |
| Applicant | NORDISK INFUSER SYSTEM 1140 CONNECTICUT AVENUE, N.W. Washington, DC 20036 |
| Contact | Michael F Cole |
| Correspondent | Michael F Cole NORDISK INFUSER SYSTEM 1140 CONNECTICUT AVENUE, N.W. Washington, DC 20036 |
| Product Code | FRN |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-02-03 |
| Decision Date | 1986-02-19 |