The following data is part of a premarket notification filed by Secured Ortho Manufacturing Of America, Llc with the FDA for Secure Wear Usa Surgical Face Mask.
| Device ID | K203101 |
| 510k Number | K203101 |
| Device Name: | Secure Wear USA Surgical Face Mask |
| Classification | Mask, Surgical |
| Applicant | Secured Ortho Manufacturing Of America, LLC 28 West Jefryn Boulevard Suite C Deer Park, NY 11729 |
| Contact | Vincent Benenati |
| Correspondent | Vincent Benenati Secured Ortho Manufacturing Of America, LLC 28 West Jefryn Boulevard Suite C Deer Park, NY 11729 |
| Product Code | FXX |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-10-14 |
| Decision Date | 2021-03-31 |