The following data is part of a premarket notification filed by Liberty Mask Llc with the FDA for Lm Surgical Mask Level 3, Lm Surgical Mask Level 2,.
Device ID | K211378 |
510k Number | K211378 |
Device Name: | LM Surgical Mask Level 3, LM Surgical Mask Level 2, |
Classification | Mask, Surgical |
Applicant | Liberty Mask LLC 1819 Firman Drive Suite 101 Richardson, TX 75081 |
Contact | Will Kincaid |
Correspondent | Timothy Kania mdi Consultants 55 Northern Blvd, Suite 200 Great Neck, NY 11021 |
Product Code | FXX |
CFR Regulation Number | 878.4040 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2021-05-04 |
Decision Date | 2021-12-16 |