The following data is part of a premarket notification filed by Texas Medplast Llc with the FDA for Savvy Mask - Level 3 Surgical Face Mask.
| Device ID | K213406 |
| 510k Number | K213406 |
| Device Name: | Savvy Mask - Level 3 Surgical Face Mask |
| Classification | Mask, Surgical |
| Applicant | Texas MedPlast LLC 6630 Roxburgh Drive #171 Houston, TX 77041 |
| Contact | Diego Olmos |
| 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 | 2021-10-19 |
| Decision Date | 2021-11-18 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10850025566138 | K213406 | 000 |
| 10850025566169 | K213406 | 000 |