The following data is part of a premarket notification filed by Ypsomed Ag with the FDA for Clickfine Autoprotect Pen Needle.
| Device ID | K152514 |
| 510k Number | K152514 |
| Device Name: | Clickfine AutoProtect Pen Needle |
| Classification | Needle, Hypodermic, Single Lumen |
| Applicant | YPSOMED AG BRUNNMATTSTRASSE 6 Burgdorf, CH Ch - 3401 |
| Contact | Stephan Affolter |
| Correspondent | Stephan Affolter YPSOMED AG BRUNNMATTSTRASSE 6 Burgdorf, CH Ch - 3401 |
| Product Code | FMI |
| CFR Regulation Number | 880.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-09-02 |
| Decision Date | 2015-11-18 |
| Summary: | summary |