The following data is part of a premarket notification filed by Ypsomed Ag with the FDA for Clickfine Autoprotect Pen Needle.
| Device ID | K110312 |
| 510k Number | K110312 |
| Device Name: | CLICKFINE AUTOPROTECT PEN NEEDLE |
| Classification | Needle, Hypodermic, Single Lumen |
| Applicant | YPSOMED AG BRUNNMATTSTRASSE 6 Burgdorf, CH Ch-3401 |
| Contact | Andre Sauter |
| Correspondent | Andre Sauter YPSOMED AG BRUNNMATTSTRASSE 6 Burgdorf, CH Ch-3401 |
| Product Code | FMI |
| CFR Regulation Number | 880.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-02-02 |
| Decision Date | 2012-01-26 |
| Summary: | summary |