The following data is part of a premarket notification filed by Altor Safety Llc with the FDA for Altor Safety 4-ply Surgical Mask (model:62232).
| Device ID | K211762 |
| 510k Number | K211762 |
| Device Name: | Altor Safety 4-Ply Surgical Mask (Model:62232) |
| Classification | Mask, Surgical |
| Applicant | Altor Safety LLC 711 Executive Boulevard Suite C Valley Cottage, NY 10989 |
| Contact | Jared Scott |
| Correspondent | Dallas L. Thomas Thomas Regulatory Resolutions, Inc. 1069 Piccadilly St. Palm Beach Gardens, FL 33418 |
| Product Code | FXX |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-06-08 |
| Decision Date | 2021-09-03 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| G023622321Z2 | K211762 | 000 |
| G023622320 | K211762 | 000 |
| 00850019086201 | K211762 | 000 |
| 00850019086638 | K211762 | 000 |