The following data is part of a premarket notification filed by Novo Nordisk Inc. with the FDA for Novofine Autocover 30g X 8mm.
| Device ID | K050106 |
| 510k Number | K050106 |
| Device Name: | NOVOFINE AUTOCOVER 30G X 8MM |
| Classification | Needle, Hypodermic, Single Lumen |
| Applicant | NOVO NORDISK INC. 100 COLLEGE ROAD WEST Princeton, NJ 08540 |
| Contact | John Signorin |
| Correspondent | John Signorin NOVO NORDISK INC. 100 COLLEGE ROAD WEST Princeton, NJ 08540 |
| Product Code | FMI |
| CFR Regulation Number | 880.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-01-18 |
| Decision Date | 2005-03-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30301691852970 | K050106 | 000 |
| 30301691852758 | K050106 | 000 |