The following data is part of a premarket notification filed by Facet Technologies Llc with the FDA for Facet 28g Universal Lancet.
| Device ID | K221433 |
| 510k Number | K221433 |
| Device Name: | Facet 28G Universal Lancet |
| Classification | Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature |
| Applicant | Facet Technologies LLC 3900 N. Commerce Dr. Atlanta, GA 30344 |
| Contact | James Bonds |
| Correspondent | James Bonds Facet Technologies LLC 3900 N. Commerce Dr. Atlanta, GA 30344 |
| Product Code | QRK |
| CFR Regulation Number | 878.4850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-05-17 |
| Decision Date | 2022-07-15 |