The following data is part of a premarket notification filed by Vr Vertical Llc Dba Xrgo with the FDA for 3-layer Medical Face Masks (xmm3l3c), 3-layer Medical Face Masks With Ties (xmm3ht).
| Device ID | K210772 |
| 510k Number | K210772 |
| Device Name: | 3-Layer Medical Face Masks (XMM3L3C), 3-Layer Medical Face Masks With Ties (XMM3HT) |
| Classification | Mask, Surgical |
| Applicant | VR Vertical LLC Dba XRGO 10645 Freeport Drive Louisville, KY 40258 |
| Contact | Matthew Dipalma |
| Correspondent | Nathaniel Victor VR Vertical Dba XRGO 10645 Freeport Drive Louisville, KY 40258 |
| Product Code | FXX |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-03-15 |
| Decision Date | 2021-09-22 |