The following data is part of a premarket notification filed by American Surgical Mask Company Llc with the FDA for Asm-301 Level 3 Surgical Mask.
| Device ID | K211440 |
| 510k Number | K211440 |
| Device Name: | ASM-301 Level 3 Surgical Mask |
| Classification | Mask, Surgical |
| Applicant | American Surgical Mask Company LLC 5508 N 50th Street Suite 1000 Tampa, FL 33610 |
| Contact | Matt Brandman |
| Correspondent | Prithul Bom REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | FXX |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2021-05-10 |
| Decision Date | 2021-06-02 |