The following data is part of a premarket notification filed by United Sewing Automation Inc. with the FDA for United Sewing High Fluid Resistant Disposable Face Mask, United Sewing High Fluid Resistant Surgical Mask, United Sewing High Fluid Resistant Procedure Mask.
| Device ID | K202697 |
| 510k Number | K202697 |
| Device Name: | United Sewing High Fluid Resistant Disposable Face Mask, United Sewing High Fluid Resistant Surgical Mask, United Sewing High Fluid Resistant Procedure Mask |
| Classification | Mask, Surgical |
| Applicant | United Sewing Automation Inc. 1772 N. Andy Griffith Parkway Mount Airy, NC 27030 |
| Contact | Benjamin Webb |
| Correspondent | Heather Hatcher Womble Bond Dickinson, US LLP One West Fourth Street Winston-salem, NC 27101 |
| Product Code | FXX |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-09-16 |
| Decision Date | 2021-05-13 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850018322003 | K202697 | 000 |