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 |