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 |