The following data is part of a premarket notification filed by Pointcore, Inc. with the FDA for Pointcore Surgical Mask.
| Device ID | K220944 |
| 510k Number | K220944 |
| Device Name: | PointCore Surgical Mask |
| Classification | Mask, Surgical |
| Applicant | PointCore, Inc. 124 SW Adams Peoria, IL 61602 |
| Contact | William Christiansen |
| Correspondent | Dave McGurl MCRA, LLC 803 7th Street, NW, 3rd Floor Washington, DC 20001 |
| Product Code | FXX |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-03-31 |
| Decision Date | 2022-09-09 |