The following data is part of a premarket notification filed by Facet Technologies, Llc with the FDA for Carefine Pen Needle With Quintapoint And Superpoint.
| Device ID | K140568 |
| 510k Number | K140568 |
| Device Name: | CAREFINE PEN NEEDLE WITH QUINTAPOINT AND SUPERPOINT |
| Classification | Needle, Hypodermic, Single Lumen |
| Applicant | FACET TECHNOLOGIES, LLC 112 TOWN PARK DR. SUITE 300 Kennesaw, GA 30144 |
| Contact | Jennifer Register |
| Correspondent | Jennifer Register FACET TECHNOLOGIES, LLC 112 TOWN PARK DR. SUITE 300 Kennesaw, GA 30144 |
| Product Code | FMI |
| CFR Regulation Number | 880.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-03-05 |
| Decision Date | 2014-05-13 |
| Summary: | summary |