The following data is part of a premarket notification filed by Novo Nordisk Inc. with the FDA for Novofine 32g Tip.
Device ID | K053470 |
510k Number | K053470 |
Device Name: | NOVOFINE 32G TIP |
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 | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2005-12-14 |
Decision Date | 2005-12-21 |
Summary: | summary |