The following data is part of a premarket notification filed by Feel Tech with the FDA for Feel-fine Insulin Pen Needle.
| Device ID | K080904 |
| 510k Number | K080904 |
| Device Name: | FEEL-FINE INSULIN PEN NEEDLE |
| Classification | Needle, Hypodermic, Single Lumen |
| Applicant | FEEL TECH PO BOX 7007 Deerfield, IL 60015 |
| Contact | Daniel Kamm |
| Correspondent | Daniel Kamm FEEL TECH PO BOX 7007 Deerfield, IL 60015 |
| Product Code | FMI |
| CFR Regulation Number | 880.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-04-01 |
| Decision Date | 2008-06-04 |
| Summary: | summary |