The following data is part of a premarket notification filed by Clearmask, Llc with the FDA for Clearmask Transparent Surgical Face Mask.
| Device ID | K200576 |
| 510k Number | K200576 |
| Device Name: | ClearMask Transparent Surgical Face Mask |
| Classification | Mask, Surgical |
| Applicant | ClearMask, LLC 900 E. Fayette St., PO Box 22493 Baltimore, MD 21203 |
| Contact | Aaron Hsu |
| Correspondent | Aaron Hsu ClearMask, LLC 900 E. Fayette St., PO Box 22493 Baltimore, MD 21203 |
| Product Code | FXX |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-03-05 |
| Decision Date | 2020-04-06 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10860005106025 | K200576 | 000 |