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 |