The following data is part of a premarket notification filed by P/l Biomedical with the FDA for Clickfine Pen Needle.
| Device ID | K122971 |
| 510k Number | K122971 |
| Device Name: | CLICKFINE PEN NEEDLE |
| Classification | Needle, Hypodermic, Single Lumen |
| Applicant | P/L Biomedical 10882 STONIGTON AVE Fort Myers, FL 33913 |
| Contact | Lee Leichter |
| Correspondent | Lee Leichter P/L Biomedical 10882 STONIGTON AVE 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 | 2012-09-26 |
| Decision Date | 2012-10-25 |
| Summary: | summary |