The following data is part of a premarket notification filed by Ypsomed Ag with the FDA for Clickfine Pen Needle, Penfine Classic Pen Needle.
| Device ID | K171984 |
| 510k Number | K171984 |
| Device Name: | Clickfine Pen Needle, Penfine Classic Pen Needle |
| Classification | Needle, Hypodermic, Single Lumen |
| Applicant | Ypsomed AG Brunnmattstrasse 6 Burgdorf, CH Ch- 3401 |
| Contact | Stephan Affolter |
| Correspondent | Lee Leichter P/L Biomedical 10882 Stonington Avenue Fort Myers, FL 33913 |
| Product Code | FMI |
| CFR Regulation Number | 880.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-06-30 |
| Decision Date | 2017-10-11 |
| Summary: | summary |