The following data is part of a premarket notification filed by Facet Technologies with the FDA for Carefine Pen Needle.
| Device ID | K133100 |
| 510k Number | K133100 |
| Device Name: | CAREFINE PEN NEEDLE |
| Classification | Needle, Hypodermic, Single Lumen |
| Applicant | FACET TECHNOLOGIES 112 TOWN PARK DR. SUITE 300 Kennesaw, GA 30144 |
| Contact | Mary Ann Kinard |
| Correspondent | Mary Ann Kinard FACET TECHNOLOGIES 112 TOWN PARK DR. SUITE 300 Kennesaw, GA 30144 |
| Product Code | FMI |
| CFR Regulation Number | 880.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-09-30 |
| Decision Date | 2014-01-23 |
| Summary: | summary |