The following data is part of a premarket notification filed by P/l Biomedical with the FDA for Clickfine Pen Needle.
Device ID | K122969 |
510k Number | K122969 |
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 |